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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9736242
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative. The system passed a system checkout and was determined to be operational. 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 the site was demonstrating a trace pattern to residents. When they went to restart the trace pattern to demonstrate the pattern again the system screen went black and they received an internal error 64. They clicked on the prompt and the system said a reboot was needed. The site clicked ok and the system reboot. After the reboot there were no issues and they continued with the case. There was no reported delay and no reported impact to patient outcome.
 
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Brand NameSTEALTHSTATION FLEXENT
Type of DeviceEAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC INC
826 coal creek cir #100
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC INC
826 coal creek cir #100
louisville CO 80027
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12129494
MDR Text Key260299707
Report Number1723170-2021-01786
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200723
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 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9736242
Device Catalogue Number9736242
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 Received09/29/2021
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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