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

Catalog Number 9735016

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2013

Event Type  malfunction  

Event Description

A medtronic ent representative reported that, while in a functional endoscopic sinus surgery (fess), a malleable suction unexpectedly stopped tracking.This occurred at approximately 25 minutes into the procedure, previously the instrument worked properly.Trouble-shooting did not resolve the issue.The surgeon opted to use an alternate instrument, a frazier straight suction, to continue and completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Rma issued.Replacement malleable suction shipped to site (b)(4) 2014.Medtronic investigation of returned suspect malleable suction finds that the tool shows red status with error "poor signal" in the system accuracy test.The suction tool will not navigate.Diagnostics in the cranial application show only 2 of 3 coils are sending data.Electrical failure - directly caused event.

• Brand Name: MALLEABLE SUCTION MEDIUM, STANDARD TIP
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 4111236
• MDR Text Key: 4702164
• Report Number: 1723170-2014-01013
• Device Sequence Number: 1
• Product Code: PGW
• 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: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/25/2013

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: 9735016
• Device Lot Number: 140530J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1