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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameFUSION¿ ENT NAVIGATION SYSTEM
Type of DeviceEAR, 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 Key8660542
MDR Text Key146775577
Report Number1723170-2019-02826
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733560XOM
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
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 Treatment Data
Date Received: 05/31/2019 Patient Sequence Number: 1
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