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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 Problem Imprecision (1307)
Patient Problem Hematoma (1884)
Event Date 04/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that after a fess procedure, the anesthesiologist in the room noticed that there was swelling around the patient's left eye. The surgeon came back into the room and used navigation with an endoscope to confirm that the patient had an orbital hematoma. The ent blade was used during the procedure with the microdebrider, but the surgeon stated the backside of the instrument was facing anterior while navigating (the blade was lateral with the cutting side facing away from the orbit), therefore it cannot be confirmed what exactly occurred to cause the hematoma. The surgeon did further dissection and inserted a drain. After the drain was placed, the swelling immediately started going down. There was a delay to the procedure of less than one hour.
 
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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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8624771
MDR Text Key145534361
Report Number1723170-2019-02484
Device Sequence Number1
Product Code PGW
UDI-Device Identifier00643169672956
UDI-Public00643169672956
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received04/24/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/22/2017
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: 05/20/2019 Patient Sequence Number: 1
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