MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PASSIVE PLANAR BLUNT PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 960-556

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The probe was returned to the manufacturer for analysis.Analysis found that the tip of the returned probe was visibly bent.However, with markers attached and fully seated, the probe returned a good geometry error and only a slightly elevated divot error that still allowed verification.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the tip om the passive planar blunt probe was bent.There was no patient present when this issue was identified.

• Brand Name: PASSIVE PLANAR BLUNT PROBE
• 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7661174
• MDR Text Key: 113174018
• Report Number: 1723170-2018-03138
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972398
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 960-556
• Device Lot Number: 120806
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2012
• 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