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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKING CAMERA ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKING CAMERA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10025
Device Problem Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, while mapping the femur in a cori sawbones demo, they received an error saying: "camera disconnected re-establish connections and press continue to reinitialize the tracking system". They pressed continue and received the following error: "camera failed to reinitialize". They press continue to try again. They went to check the ethernet cable and observed two solid red lights on the back of the camera. They exited the case, swapped ethernet cables, and when they got to the connection screen, the camera would not connect. They powered down the system and rebooted it. When they got back to the connection screen, the camera was able to connect. However once again, when they painted the femur the camera had the same set of errors as described above. Quality recommended resetting the shock sensor. They attempted to perform this; however, when they were in the code input screen, the console was unable to connect with the camera. It said "searching for devices. Error: cannot fins any device". They restarted the system and tried this again and received the same error. Finally they attempted to get through registration as quickly as possible to see if they could get to the planning screen. They were able to do this and the camera did not go down. They even collected joint laxity and burred the distal femur. After that, they opened a uka case and went through the entire workflow except for cutting. No case involved; therefore, there was no patient involvement. It is unknown if the issue is from camera or console.
 
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Brand NameREAL INTELLIGENCE TRACKING CAMERA
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 Key13957675
MDR Text Key288281230
Report Number3010266064-2022-00233
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10025
Device Catalogue NumberROB10025
Was Device Available for Evaluation? No
Date Manufacturer Received03/09/2022
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 Unkown

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