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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 Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2020
Event Type  Injury  
Event Description
It was reported that when setting up for a navio tka procedure, the camera connection said disconnected. The cable connection was checked on both navio system and camera. The back of navio was also opened and checked. The camera would make three beep noises as if trying to connect but would then go back to disconnected on screen. The procedure was continued with manual instruments. No other complications were reported. When the camera cable was replaced, the camera connected.
 
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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
rick confer
2828 liberty avenue
suite 100, PA 15222
4126833844
MDR Report Key10558612
MDR Text Key207692121
Report Number3010266064-2020-01781
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSR200027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/21/2020 Patient Sequence Number: 1
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