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

Catalog Number 9735016

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that a malleable suction was unable to be navigated during functional endoscopic sinus surgery (fess) procedure after it was able to be navigated previously during the surgery.The 70 degree curved suction was verified and then the malleable suction could no longer be tracked.Each instrument was connected to different ports.All other instruments were also connected and able to be tracked without any issues.Another malleable suction was connected and also could not be tracked.The surgeon opted to complete the procedure with the other navigated instruments and not the malleable suction.There was no impact to the patient.

Manufacturer Narrative

Patient information was not provided.Device manufacture date was unavailable as no lot number was provided.Evaluation was not possible as the device was discarded by the site.The account team confirmed there have not been any other issues with instrument tracking.The system was functioning normally with no need for additional service.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027 ; 7208902082
• MDR Report Key: 4358982
• MDR Text Key: 5238175
• Report Number: 1723170-2014-01365
• 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: 09/29/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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