VLOCL1545

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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>V-Loc™ 180 absorbable wound closure devices are indicated for use during surgical interventions where use of an absorbable suture is appropriate. The intended purpose of the device is soft tissue approximation.</p> <h3>Contraindictions</h3> <ul> <li>The use of the V-Loc™ 180 absorbable wound closure device is contraindicated in patients with known sensitivities or allergies to its components.</li> <li>The V-Loc™ 180 absorbable wound closure device is not for use where prolonged (beyond 3 weeks) approximation of tissues under stress is required or for fixation of prosthetic devices (e.g., heart valves or synthetic grafts).</li> <li>The V-Loc™ 180 absorbable wound closure device should not be used for interrupted suture patterns.</li> <li>The V-Loc™ 180 absorbable wound closure device is not intended to be used by tying surgical knots.</li> <li>The V-Loc™ 180 absorbable wound closure device should not be used for ligating vessels or luminal structures.</li> </ul> <h3>Warnings and precautions</h3> <ul> <li>The safety and effectiveness of the V-Loc™ 180 absorbable wound closure device has not been established for use in fascial closures (abdominal wall, thoracic, extremity fascial closures), osseous tissue, tendinous tissue, gastrointestinal anastomoses, cardiovascular anastomoses, neurological, ophthalmic or microsurgery.</li> <li>Barbed sutures should be used carefully; cut the suture flush with tissue and bury any ends to avoid inadvertent attachment to the small bowel, mesentery, and other tissues.</li> <li>V-Loc™ 180 absorbable wound closure device is intended to be used without the use of anchoring knots to begin or terminate the suture line. Do not tie knots. Tying knots may damage the barbs and potentially reduce their effectiveness.</li> <li>Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure. </li> <li>Small bowel obstructions due to barbed suture ends hooking onto adjacent small bowel and/or mesentery have been reported; these are potentially associated with volvulus, bowel infarction, and significant morbidity.</li> <li>Suture failure may result in bleeding, wound dehiscence, or infection.</li> <li>This device is provided sterile for single-use only. Sterile unless packaging has been opened or damaged. Visually inspect package before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.</li> <li>Intended users are healthcare professionals who have been trained in surgical procedures and techniques involving absorbable sutures. Before employing the V-Loc™ 180 devices for wound closure, users should be familiar with surgical procedures, techniques, size choice, and tensile strength profiles as the risk of wound dehiscence may vary with the site of application and the device material used.</li> <li>Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion, delayed absorption and sterile abscess may occur.</li> <li>V-Loc™ 180 absorbable wound closure device should only be used with continuous suture patterns. Do not use V-Loc™ 180 absorbable wound closure device in a continuous locking pattern.</li> <li>Acceptable surgical practice must be followed with respect to the management of contaminated or infected wounds.</li> <li>The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.</li> <li>The use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support. </li> <li>In surgery of the urinary and biliary tracts, care should be taken to avoid prolonged contact of this, or any other device with salt solutions, as calculus formation may result.</li> <li>In handling this or any other device, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. </li> <li>Since foreign material in the presence of bacterial contamination may enhance bacterial infectivity, standard surgical practice should be followed with respect to drainage and closure of infected wounds. The V-Loc™ 180 absorbable wound closure devices did not enhance infection in animal studies. Dispose of used devices and packaging materials in accordance with standard hospital procedures and universal precautions for biohazardous waste.</li> <li>During employment of the device, care should be taken to avoid damage to the surgical needles from handling. Grasp the needle in an area one-third to one half of the distance from the attachment end to the needle point. Grasping near the point could result in damage to the functional integrity or fracture the needle. Grasping at the attachment area could cause breakage of the needle barrel or the absorbable suture in the attachment area. Reshaping needles may result in decreased resistance to bending and breaking. To avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens, the user should exercise caution during handling of surgical needles and consider use of Protect Point™ modified taper needles where appropriate.</li> <li>Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements. “Sharps” should be disposed of in accordance with end user’s sharps containment, handling, and disposal procedures. Use caution during handling and disposal to avoid injury.</li> </ul> <h3>Indications</h3> <p>V-Loc™ 90 absorbable wound closure devices are indicated for use during surgical interventions where use of an absorbable suture is appropriate. The intended purpose of the device is soft tissue approximation. </p> <h3>Contraindications</h3> <ul> <li>The use of the V-Loc™ 90 absorbable wound closure device is contraindicated in patients with known sensitivities or allergies to its components.</li> <li>The V-Loc™ 90 absorbable wound closure device is not for use where prolonged (beyond 2 weeks) approximation of tissues under stress is required or for fixation of prosthetic devices (e.g., heart valves or synthetic grafts).</li> <li>The V-Loc™ 90 absorbable wound closure device should not be used for interrupted suture patterns.</li> <li>The V-Loc™ 90 absorbable wound closure device is not intended to be used by tying surgical knots.</li> <li>The V-Loc™ 90 absorbable wound closure device should not be used for ligating vessels or luminal structures.</li> </ul> <h3>Warnings and precautions</h3> <ul> <li>The safety and effectiveness of the V-Loc™ 90 absorbable wound closure device has not been established for use in fascial closures (abdominal wall, thoracic, extremity fascial closures), osseous tissue, tendinous tissue, gastrointestinal anastomoses, cardiovascular anastomoses, neurological, ophthalmic or microsurgery.</li> <li>Barbed sutures should be used carefully; cut the suture flush with tissue and bury any ends to avoid inadvertent attachment to the small bowel, mesentery, and other tissues.</li> <li>The V-Loc™ 90 absorbable wound closure device is intended to be used without the use of anchoring knots to begin or terminate the suture line. Do not tie knots. Tying knots may damage the barbs and potentially reduce their effectiveness.</li> <li>Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure. </li> <li>Small bowel obstructions due to barbed suture ends hooking onto adjacent small bowel and/or mesentery have been reported; these are potentially associated with volvulus, bowel infarction, and significant morbidity.</li> <li>Suture failure may result in bleeding, wound dehiscence, or infection.</li> <li>This device is provided sterile for single use only. Sterile unless packaging has been opened or damaged. Visually inspect the package before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.</li> <li>Intended users are healthcare professionals who have been trained in surgical procedures and techniques involving absorbable sutures. Before employing the V-Loc™ 90 devices for wound closure, users should be familiar with surgical procedures, techniques, size choice, and tensile strength profiles as the risk of wound dehiscence may vary with the site of application and the device material used.</li> <li>Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion, delayed absorption and sterile abscess may occur.</li> <li>V-Loc™ 90 absorbable wound closure device should only be used with continuous suture patterns. Do not use V-Loc™ 90 absorbable wound closure device in a continuous locking pattern.</li> <li>Acceptable surgical practice must be followed with respect to the management of contaminated or infected wounds.</li> <li>The use of this suture may be inappropriate for patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing.</li> <li>The use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support.</li> <li>In surgery of the urinary and biliary tracts, care should be taken to avoid prolonged contact of this, or any other device with salt solutions, as calculus formation may result.</li> <li>In handling this or any other device, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. </li> <li>Since foreign material in the presence of bacterial contamination may enhance bacterial infectivity, standard surgical practice should be followed with respect to drainage and closure of infected wounds. The V-Loc™ 90 absorbable wound closure devices did not enhance infection in animal studies. Dispose of used devices and packaging materials in accordance with standard hospital procedures and universal precautions for biohazardous waste.</li> <li>During employment of the device, care should be taken to avoid damage to the surgical needles from handling. Grasp the needle in an area one-third to one half of the distance from the attachment end to the needle point. Grasping near the point could result in damage to the functional integrity or fracture the needle. Grasping at the attachment area could cause breakage of the needle barrel or the absorbable suture in the attachment area. Reshaping needles may result in decreased resistance to bending and breaking. To avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens, the user should exercise caution during handling of surgical needles and consider use of Protect Point™ modified taper needles where appropriate.</li> <li>Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements. “Sharps” should be disposed of in accordance with end user’s sharps containment, handling, and disposal procedures. Use caution during handling and disposal to avoid injury.</li> </ul> <h3>Indications</h3> <p>V-Loc™ PBT non-absorbable wound closure devices are indicated for use during surgical interventions. The intended purpose of the device is soft tissue approximation.</p> <h3>Contraindications</h3> <ul> <li>The use of the V-Loc™ PBT non-absorbable wound closure device is contraindicated in patients with known sensitivities or allergies to its components.</li> <li>The V-Loc™ PBT non-absorbable wound closure device should not be used for interrupted suture patterns.</li> <li>The V-Loc™ PBT non-absorbable wound closure device is not intended to be used by tying surgical knots.</li> <li>V-Loc™ PBT non-absorbable wound closure device is not intended to be used in direct contact with the heart, the central circulatory system or the central nervous system.</li> </ul> <h3>Warnings and precautions</h3> <ul> <li>The safety and effectiveness of the V-Loc™ PBT non-absorbable wound closure device has not been established for use in fascial closures (abdominal wall, thoracic, extremity fascial closures), osseous tissue, tendinous tissue, gastrointestinal anastomoses, cardiovascular anastomoses, neurological, ophthalmic or microsurgery. </li> <li>Barbed sutures should be used carefully; cut the suture flush with tissue and bury any ends to avoid inadvertent attachment to the small bowel, mesentery, and other tissues.</li> <li>The V-Loc™ PBT non-absorbable wound closure device is intended to be used without the use of anchoring knots to begin or terminate the suture line. Do not tie knots. Tying knots may damage the barbs and potentially reduce their effectiveness.</li> <li>Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure. </li> <li>Small bowel obstructions due to barbed suture ends hooking onto adjacent small bowel and/or mesentery have been reported; these are potentially associated with volvulus, bowel infarction, and significant morbidity. </li> <li>Suture failure may result in bleeding, wound dehiscence, or infection.</li> <li>This device is provided sterile for single-use only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the packaging and the sterile barrier system before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment or life-threatening injury.</li> <li>Before employing the V-Loc™ PBT devices for wound closure, users should be familiar with surgical procedures, techniques, size choice, and tensile strength profiles as the risk of wound dehiscence may vary with the site of application and the device material used.</li> <li>The V-Loc™ PBT non-absorbable wound closure device should only be used with continuous running suture patterns. Do not use V-L oc™ PBT non-absorbable wound closure device in a continuous locking pattern.</li> <li>Acceptable surgical practice must be followed with respect to the management of contaminated or infected wounds.</li> <li>The use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites subject to expansion, stretching or distention, or requiring additional support. </li> <li>In surgery of the urinary and biliary tracts, care should be taken to avoid prolonged contact of this, or any other device with salt solutions, as calculus formation may result.</li> <li>In handling this or any other device, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. </li> <li>During employment of the device, care should be taken to avoid damage to the surgical needles from handling. Grasp the needle in an area one-third to one-half of the distance from the attachment end to the needle point. Grasping near the point could result in damage to the functional integrity or fracture the needle. Grasping at the attachment area could cause breakage of the needle barrel or the non-absorbable suture in the attachment area. Reshaping needles may result in decreased resistance to bending and breaking. To avoid inadvertent needle stick injury, which may result in transmission of blood-borne pathogens, the user should exercise caution during handling of surgical needles and consider use of Protect Point™ modified taper needles where appropriate.</li> <li>Dispose of used instruments in accordance with the end-user’s medical and biological waste disposal requirements. “Sharps” should be disposed of in accordance with end user’s sharps containment, handling, and disposal procedures. Use caution during handling and disposal to avoid injury.</li> <li>The device contains nickel that may cause allergic reaction.</li> </ul>

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