MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 70 DEG CURVED SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733450
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic area representative was onsite when the reported event occurred.Issue was resolved when site used an alternative instrument and they were able to successfully continue the case.Reported instrument was not returned to manufacturer for analysis, therefore, no findings are possible.Part not returned.
Event or Problem Description
A medtronic representative reported that while in a functional endoscopic sinus surgery (fess), the (b)(6) degree curved suction instrument was damaged.The surgeon continued the surgery using another instrument.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
Additional information: upon further follow-up, it was reported that the suction was bent.The damaged instrument was replaced.

• Brand Name: 70 DEG CURVED SUCTION, AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6461787
• Report Number: 1723170-2017-01504
• Device Sequence Number: 10881657
• Product Code: HAW
• UDI-Device Identifier: 00613994378477
• UDI-Public: 00613994378477
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• 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,Followup
• Report Date (Section B): 07/14/2017

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: 9733450
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 130