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

Model Number 9735602

Device Problems Human-Device Interface Problem (2949); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product: 9735546; lot #: 160422.A medtronic representative went to the site to test the equipment.Testing revealed that there was damaged to usb cpu cable causing intermittent connection of the axiem.The parts were replaced and the failure resolved.A hardware analysis was initiated to determine the probable cause of the issue.Analysis found that returned cable was bent at the usb connection.The connector was not usable as is.The reported event was related to an anomaly in the medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that a damaged communication cable creating intermittent red x appeared to be loose.There was no patient present when this issue was identified.

• 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: 8916571
• MDR Text Key: 155102808
• Report Number: 1723170-2019-04579
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• 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: 08/05/2019
• Date Manufacturer Received: 07/29/2019
• 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