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

Model Number 9735019

Device Problem Output Problem (3005)

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

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Device lot number and udi unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported the site was having issues with tracking the malleable suction with intermittent tracking visibility.It was known that they tried using different ports and checked the tracking details.They grabbed a new suction plugged it in and the tracking details had said poor signal.No metal was introduced into the field and all metal was taken away to help improve the tracking signal.The manufacturer representative present had noticed that the surgeon was holding the suction and bending it at the base of the instrument causing the wires to be pinched.The manufacturer representative recommended trying a different technique and tracking had worked for the rest of the case with no issues.This issue occurred intraoperatively and caused a less than 5-minute surgical delay.There was no reported impact on patient outcome.

Manufacturer Narrative

The suction was returned to the manufacturer for analysis.Analysis found coils #2 and #3 were not functioning causing the inability to track.Analysis found that the reported event was related to a electrical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MALLEABLE SUCTION
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9385265
• MDR Text Key: 181552415
• Report Number: 1723170-2019-05813
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: 9735019
• Device Catalogue Number: 9735019
• Device Lot Number: 190206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2019
• 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: 74 YR
• Patient Weight: 84