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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR200027
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2021
Event Type  malfunction  
Event Description
It was reported that, during set up for a navio assisted surgery, the error "camera infra red lamp is not working properly. This may result in limited field of view. " was received. The amber led on the camera was active. The procedure was completed with the same device without delay. The patient was not harmed.
 
Manufacturer Narrative
Internal complaint reference case: (b)(4).
 
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Brand NameNDI CAMERA POLARIS SPECTRA
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 Key13095762
MDR Text Key286743660
Report Number3010266064-2021-00909
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSR200027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/28/2021 Patient Sequence Number: 1
Treatment
ROB00036/NAVIO SURGICAL SYSTEM (B)(6)
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