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

Catalog Number 9735015

Device Problems Imprecision (1307); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

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 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
• Type of Device: EAR, NOSE, AND THROAT 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6229074
• MDR Text Key: 64057593
• Report Number: 1723170-2017-00058
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169443501
• UDI-Public: 00643169443501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Catalogue Number: 9735015
• Device Lot Number: 160725-B
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 72 YR
• Patient Weight: 108