VS101505

Product image of the VersaStep™ bladeless trocar

Indications, Safety, and WarningsWarnings and precautions

Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques. A thorough understanding of the operating principles, risks versus benefits, and the hazards involved in utilizing an endoscopic approach is necessary to avoid possible injury to the user and/or patient.

Verify mechanical and electrical compatibility of devices from different manufacturers prior to using them together in a procedure.

Proper technique for the insertion of the VersaStep™ device , as with any endoscopic access device, must be used. Exercise caution during insertion/dilation to avoid damage to internal organs. Consult the literature for information regarding safe techniques.

Greater resistance will be felt at the point where the radially expandable sleeve meets the tissues as compared with a bare insufflation/access needle.

Insert the dilator/cannula straight through the center of the radially expandable sleeve. Inserting the dilator/cannula at an angle can cause damage to the sleeve by tearing through the side of the sleeve. If the sleeve becomes torn or damaged, obtain a new radially expandable sleeve and insert the dilator/cannula as described above.

If removing the cannula/radially expandable sleeve from the abdominal cavity, desufflate the abdomen first by opening the stopcock on the side of the cannula. Leave the laparoscope in place in the cannula. Remove the cannula and radially expandable sleeve leaving the laparoscope in the remaining defect. This allows complete visualization of intact abdominal contents. Failure to follow the above steps may result in exteriorization of abdominal contents through the radially expandable sleeve.

The VersaStep™ single-use components can only be used together and with the VersaStep™ expandable sleeve. Products that resemble VersaStep™ components manufactured by other manufacturers cannot be used with the VersaStep™ single-use components. To do so would compromise the performance of the product and create a patient safety hazard.

This device is provided sterile and is intended for use in a single procedure only. Discard after use. Do not resterilize.

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