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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735602
Device Problems Device Sensing Problem (2917); Environmental Compatibility Problem (2929)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a functional endoscopic sinus surgery (fess). It was reported that the power automatically shut down. After that, the instrument tracker had recognition failure. The electromagnetic (em) blade was recognized. There was a delay of less than one hour and no impact to the patient. Additional information was received. The system was plugged in to a known, functional outlet when it shut down. The recognition failure of the tracker was clarified to mean that the tracker could not be verified and this could not be resolved through troubleshooting. It was noted that this was an issue with the system and not the tracker although the exact cause of the recognition failure was unknown. The cause of the system shutting down was not known.
 
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Brand NameFUSION COMPACT
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10642771
MDR Text Key210242573
Report Number1723170-2020-02635
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153247
Number of Events Reported1
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 10/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735602
Device Catalogue Number9735602
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 Received09/15/2020
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

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