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

Model Number 9735602

Device Problem Environmental Compatibility Problem (2929)

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

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information will not be provided due to (b)(6) legal/confidential reasons.Issue was resolved by moving the usb from the bottom port to the top port.No information of a system checkout has been received.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used prior to a functional endoscopic sinus surgery.It was reported that the system was placed on the operating table and powered on.The system would power off if the table was moved a little.The system had to be started up three times.The issue was resolved after the usb cable was moved from the port in the bottom of the main unit screen to the port in the top.The operation was completed without issue.The suspected probable cause was thought to be an issue with the bottom usb port.The system was plugged into a power strip that is normally used and functional.There was no patient harm and the procedure was not delayed.

• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10369158
• MDR Text Key: 201764912
• Report Number: 1723170-2020-02107
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: No
• 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