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

Model Number 9733560XOM

Device Problems Insufficient Cooling (1130); Human-Device Interface Problem (2949)

Patient Problems Tissue Damage (2104); Iatrogenic Source (2498)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

Device udi number unavailable.A medtronic representative went to the site to test the equipment.The navigation system passed the system checkout and was found to be fully functional.No parts were replaced on the system.Device manufacturing date 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 for a functional endoscopic sinus surgery (fess).It was reported that when getting ready for the case, a high temperature warning was displaying on the navigation system.The overheating error message occurred as the surgeon was trying to register (prior to registration).The system was rebooted and the surgeon was able to register, but then none of their instruments would track.Additionally, it was reported that the site did not know how to make it so the images were stationary in the views during the case.Technical services (ts) explained the cross-hair movement option and instructed them to call into tech support in the future for issues.Due to the reported issues, the surgeon decided to abort navigation and also decided to abort the surgery.Anesthesia was administered to the patient prior to the surgery being aborted.A medtronic representative believed that an incision had been made prior to the surgery being aborted.It was stated that the surgery was going to be rescheduled but the date had yet to be determined.There was a surgical delay of less than 1 hour due to this issue.There was no impact on patient outcome, and the patient experienced no symptoms due to the reported event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that an incision had not been made prior to the surgery being aborted.

Manufacturer Narrative

Device evaluation: a software investigation was initiated but was unable to determine probable cause without further information since the behavior could not be replicated following a passing system checkout.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• 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: 8660542
• MDR Text Key: 146775577
• Report Number: 1723170-2019-02826
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 06/06/2019; 08/15/2019
• Supplement Dates FDA Received: 07/03/2019; 08/22/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 82