MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OSTIUM SEEKER PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9732374
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that the registration probe straight suction was deformed.The procedure was completed using the navigation with no patient impact.No delay in surgery was reported.
Additional Manufacturer Narrative
The probe was returned to the manufacturer for analysis.The returned probe is well worn with many nicks and scratches.The probe array was loose, rotating under its own weight.However, with markers attached and fully seated, the probe returned good geometry and divot error readings verifying without issue.The device was found to be fully functional.The reported event could not be duplicated by medtronic personnel.
Additional Manufacturer Narrative
Additional information: device manufacture date provided.

• Brand Name: OSTIUM SEEKER PROBE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6435602
• Report Number: 1723170-2017-01331
• Device Sequence Number: 16150630
• Product Code: HAW
• UDI-Device Identifier: 00613994128195
• UDI-Public: 00613994128195
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2017

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: Health Professional
• Device Catalogue Number: 9732374
• Device Lot Number: 12454A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 05/31/2017; 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1