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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 Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Event Description
It was reported that, during machine setup before a navio procedure, it was found that the camera was not getting connected.The two green leds on the polaris camera were solid as normal.Also, the usb cables were reconnected from cpu; the camera cable was also reconnected.However, the camera could not establish connection.On the hardware connect screen, it was shown that the camera was not getting connected.There was no patient involvement.No other complications were reported.
 
Manufacturer Narrative
Confirmation received that the camera was not faulty.Internal complaint reference: case-(b)(4).Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the device did not cause or contribute to a death or serious injury, nor has it been implicated by a physician as having caused such injury.It was confirmed that the camera did not malfunction, and that there was no deterioration in the characteristics or performance of the device.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
NDI CAMERA POLARIS SPECTRA
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
MDR Report Key11793971
MDR Text Key249661072
Report Number3010266064-2021-00338
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556649541
UDI-Public885556649541
Combination Product (y/n)N
PMA/PMN Number
K152574
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPFSR200027
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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