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1898200TRF

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The StraightShot™ M4 microdebrider enables simultaneous resection & suction of soft/hard tissue in ENT, supporting up to 12k rpm and high-speed burs.

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Indications, Safety, and WarningsStraightshot™ microdebrider Device descriptionThe Straightshot™ microdebrider is designed to accommodate a number of otorhinolaryngology procedures, including functional endoscopic sinus surgery (FESS), adenoidectomy, removal of laryngeal and vocal cord lesions, rhinoplasty, dermabrasion, and submental lipectomy. A variety of disposable blades and burs are available for this purpose.
Indications
Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidectomy, and medial, lateral, and posterior frontal sinusotomy.Nasopharyngeal/laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy, tonsillotomy for obstructive tonsillar disease, removal of endobronchial lesions and surgical management of recurrent respiratory papillomatosis (RRP).Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.ContraindicationsNone are known.Warnings

Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.

For airway blades: Should the blade become clogged during use, risk assessment has determined 1–5 cc of irrigant could be aspirated by the patient before detection by the user.

Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories.

Do not use burs above the speed indicated on the bur label.

For high-speed drilling (greater than 6,000 rpm), ensure that an XPS high speed bur is used.

Use adequate irrigation from a separate user-provided irrigating source. The use of an accessory without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.

Disposable devices are for single use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination, use only once.

Insertion of metal objects in blade or bur tip may cause the blade or bur to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation, and foreign-body response at surgical site.

Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.

Bending or prying may break the blade or bur, causing harm to patient or staff.

Operate the blade or bur only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.

Blades, burs, and irrigation tubing are disposable and intended for single use only, unless otherwise marked.

Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.

Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.

Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS accessories. The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.

Employ visualization when using rotating XPS accessories, including use of image-guided surgery system if needed. Discontinue powered application in the event of lack of visualization of the surgical site.

Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.

Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.

Do not use any parts other than Medtronic system components as damage or substandard performance could result.

Remove and discard accessories following local regulations for proper disposal of contaminated materials.

Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross contamination.

Use lock on Straightshot™ M4 and M5 handpieces to prevent inadvertent rotation of blade or bur during use.

It is important that the XPS 3000 operator be familiar with the system user’s guide, its precautions, procedures, and safety issues.

Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.

Excessive pressure applied to bur may cause bur fracture. Should a bur fracture occur during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.

Surgical precautions

The Straightshot™ Magnum™ II and Straightshot™ M4 and M5 high-speed microdebriders are intended to operate at speeds greater than 6,000 rpm only when used with the XPS high-speed bur line.

XPS™ blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade. XPS™ burs should be operated in the forward mode only.

To prevent damage to curved blades and burs, disconnect suction tube prior to changing blade or bur during procedure.

Be sure the blade is fully engaged in the microdebrider and verify the tip is fully engaged with the outer cannula prior to use.

1898200TRF

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United States

Customer Care Team

1898200TRF

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