MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MALLEABLE SUCTION LARGE, STANDARD TIP; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number	9735019
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Manufacture date was not available at the time of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that the large malleable suction stopped navigating during the case.There was no signal.It worked for half of the case then all of a sudden it stopped tracking.Troubleshooting involved the site opening a new suction and it resolved the problem.No impact on patient outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received: the suction was used with ent software and a flat emitter.A manufacturer representative stated that the potential cause of why the suction stopped tracking was that the imbedded wire got severed or a short occurred in the connector or wire.

• Brand Name: MALLEABLE SUCTION LARGE, STANDARD TIP
• Common Device Name: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8484325
• Report Number: 1723170-2019-01546
• Device Sequence Number: 19336631
• Product Code: PGW
• UDI-Device Identifier: 00643169443549
• UDI-Public: 00643169443549
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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 Model Number: 9735019
• Device Catalogue Number: 9735019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 122