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

Model Number 9735602

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

Device udi is not available.A medtronic representative went to the site to test the equipment.Testing revealed that the emitter details showed there was a communication error in both em box and the emitter along with red lines.The representative replaced the box and the power cable.The system then passed the system checkout and was found to be fully functional.Device manufacturing date is 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 intra/peri-operatively of a functional endoscopic sinus surgery (fess) procedure.It was reported that, while setting up for a case, the navigation system was showing a communication error in the emitter details, but the equipment screen shows green line of communication and the emitter is chirping.The representative tried re-booting the emitter box and the navigation system, as well as reconnecting the communication cable with no resolution.When the emitter was disconnected from the emitter box, the communication was restored.However, the surgeon aborted navigation and the procedure was completed without the use of navigation.There was a 30-minute delay to the procedure and no impact on patient outcome.

Manufacturer Narrative

Analysis on the returned em cable and emitter resulted in no failure being found for both devices through functional testing and visual/physical examination.Analysis states that the returned cable passed the continuity test.Analysis on the returned emitter showed when used on a test system, the system remained in green status during all testing.Analysis on the returned em system resulted in an electrical failure that was found through functional testing and visual/physical ex amination.Analysis states that, when used on test system, after several hours of testing, the unit stopped tracking.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• 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: 8696042
• MDR Text Key: 147903662
• Report Number: 1723170-2019-03292
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• 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: 07/08/2019

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 Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 60 YR
• Patient Weight: 59