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

Model Number 9735602

Device Problems Connection Problem (2900); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the emitter system, emitter cable and emitter generator was replaced.The system then passed the system checkout and was found to be fully functional.No devices were returned to the manufacturer for analysis.Device manufacturing date is unavailable.Concomitant medical products: product id: 9660651.Product id: 9731203.Product id: 9735546.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 the registration was completed without any problems.An attempt was made to use the device in a sterile field, but the instrument was not recognized and the emitter was not connected on the equipment screen.A reboot was performed and call cables were reconnected without resolution.The site discontinued navigation to complete the procedure.There was no delay in the procedure and no impact on patient outcome.

Manufacturer Narrative

Additional information: analysis on the returned emitter cable has no failure found when analyzed.Analysis states that it passed continuity test with no opens or shorts.Continuation of concomitant medical product: pn: 9735546, lot #: 191114.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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10922978
• MDR Text Key: 218937015
• Report Number: 1723170-2020-03125
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153247
• 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,Followup
• Report Date: 01/04/2021

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: 12/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/04/2021
• 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