MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BALL TIP PROBE - 4.3MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9731965
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An onsite medtronic representative was onsite when this event occurred, they confirmed that the instrument was damaged.Replacement of the instrument resolved the issue.No further issues were reported.Analysis of the returned instrument confirmed the physical damage as the issue was replicated due to a bent support arm yielding high geometry error.
Event or Problem Description
A medtronic representative reported that while in a cranial resection procedure, one of the spheres on the probe was showing red in the camera tracking view of the navigation system.They switched spheres and it still showed red.When examining the probe closer it appeared that a post was bent.They attempted to bend it back, but afterward the probe would no longer verify.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.

• Brand Name: BALL TIP PROBE - 4.3MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6347519
• Report Number: 1723170-2017-00482
• Device Sequence Number: 550124
• Product Code: HAW
• UDI-Device Identifier: 00885074328195
• UDI-Public: 00885074328195
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 9731965
• Device Lot Number: 120919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 119