MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MALLEABLE SUCTION SMALL, STANDARD TIP; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	9735015
Medical Device Problem Codes	Imprecision (1307); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturing date is unavailable.Return requested.Replacement malleable suction shipped to site (b)(6) 2016.No parts have been received by manufacturer for analysis.
Event or Problem Description
A site representative, x-ray technician, reported that while in an ear, nose & throat (ent) procedure, their malleable suction was damaged.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon alleged a 1 centimeter inaccuracy occurred.The malleable suction was appearing as too long in the software.All other instruments were accurate.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: MALLEABLE SUCTION SMALL, STANDARD TIP
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6229074
• Report Number: 1723170-2017-00058
• Device Sequence Number: 11030369
• Product Code: PGW
• UDI-Device Identifier: 00643169443501
• UDI-Public: 00643169443501
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2017

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: 9735015
• Device Lot Number: 160725-B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 108