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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 02/25/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference number: case-(b)(4).
 
Event Description
It was reported that when they powered on the cori machine for a tka procedure and added the patient's information, an error massage saying "incompatible camera firmware" appeared. They switched off machine, switched it on again, went to admin and updated camera firmware again. They followed troubleshooting guide, switched off machine, unplugged and plugged back camera, foot pedal, ether-net cable, powered off, waited for 1 min, powered on again, turned camera facing the wall, and proceed again to case setting up, but the same "incompatible camera firmware" appeared. So, they quit, proceed to admin to update firmware again, went back to case and same "incompatible camera firmware" message appeared. Therefore, they informed surgeon that the machine was not ready and surgeon proceed with conventional manual procedure. No patient injury was reported. After the procedure was changed, the development manager repeated the steps listed above with same conditions and she was able to proceed to case creation and burr selection as per normal. No delay was reported. No other complications were reported.
 
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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 Key11528583
MDR Text Key241025851
Report Number3010266064-2021-00212
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K201022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10025
Device Catalogue NumberROB10025
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
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 Reuse

Patient Treatment Data
Date Received: 03/19/2021 Patient Sequence Number: 1
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