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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CAMERA, POLARIS VEGA ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES CAMERA, POLARIS VEGA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 200597
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2020
Event Type  malfunction  
Event Description
It was reported that, during a navio tka procedure, the message "infrared bulb of the camera is not working correctly, camera view could be affected. " popped up. They hide the message and were able to finish the surgery without delays. No other complications were reported.
 
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Brand NameCAMERA, POLARIS VEGA
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10911268
MDR Text Key218506552
Report Number3010266064-2020-02041
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number200597
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 Received07/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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