Surgical Instruments

There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

The kit contains a non-sterile needle.

Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.

Potential for open packaging seals compromising the sterility of the surgical gowns

Potential for open packaging seals compromising the sterility of the surgical gowns

Potential for open packaging seals compromising the sterility of the surgical gowns

Potential for open packaging seals compromising the sterility of the surgical gowns

Potential for open packaging seals compromising the sterility of the surgical gowns

Potential for open packaging seals compromising the sterility of the surgical gowns

Potential for open packaging seals compromising the sterility of the surgical gowns

Potential for open packaging seals compromising the sterility of the surgical gowns

Product is not approved for use in the EU and should not have been distributed in the EU.

Potential for open packaging seals compromising the sterility of the surgical gowns