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

Device Problem Excessive Cooling (2932)

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

Event Date 09/25/2019

Event Type  malfunction  

Event Description

Ent fusion navigation machine froze twice during the surgical case.The machine had to be rebooted approximately six times.The second time, it froze and had to be rebooted and still did not work.The surgeon asked for an image guidance machine to be borrowed from outside hospital.At his time, the team leader was able to reach out to the company representative and had a loaner fusion machine brought in for the case.The procedure continued without the use of image guidance machine for an hour.

• Brand Name: FUSION COMPACT
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek cir.; louisville CO 80027
• MDR Report Key: 9266603
• MDR Text Key: 164645214
• Report Number: 9266603
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4745 DA