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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 Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. Missing udi. A medtronic representative went to the site to test the equipment. Testing revealed that the system was functioning as intended. The system passed the system checkout and was found to be fully functional. Missing device manufacture date. 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) procedure. It was reported that the system became unresponsive. On the select patient screen, when the site tried to choose a patient, the mouse would move but the software would not respond to any input from the touchscreen or mouse clicks. Site rebooted the system and were able to select a patient, but the system became unresponsive again when trying to choose a different exam. Site removed the cd from the drive, checked that there were no additional flash drives on the system, and rebooted a third time. This time they were able to get to the equipment screen before the system became unresponsive. After a 4th reboot the site was able to get to the registration screen, successfully register, and then navigate. System had 91% free space. A software uninstall and reinstall resolved the issue. There was no patient impact reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: there was no delay to surgery. If information is provided in the future, a supplemental report will be issued.
 
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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 Key8200071
MDR Text Key131519585
Report Number1723170-2018-06448
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 03/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
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 Received03/20/2019
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

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