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

Catalog Number 9731965

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

Event Type  malfunction  

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 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
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: sam saleh ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6347519
• MDR Text Key: 67940789
• Report Number: 1723170-2017-00482
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00885074328195
• UDI-Public: 00885074328195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 119