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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9736242
Device Problems Communication or Transmission Problem (2896); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
Event Type  malfunction  
Event Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess). It was reported that the system suddenly froze and did not show the health care professional where they were. Nothing could be changed on the screen. The site performed a hard reset. There was less than an hour delay in the case. No impact on patient outcome.
 
Manufacturer Narrative
The manufacturer representative went to the site to test the navigation system. No hardware parts were replaced. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION FLEXENT
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13003072
MDR Text Key287328747
Report Number1723170-2021-02884
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K200723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
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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