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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE FOOT PEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE FOOT PEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10026
Device Problem Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, during the femur mapping stage in a cori assisted surgery, the error "foot pedal cable disconnected" popped on screen. After resetting the foot pedal connection, the error "pedal cable disconnected" appeared during the femur cut stage. The surgery was completed with manual instrumentation with a significant delay. The patient was not harmed beyond the reported problem.
 
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Brand NameREAL INTELLIGENCE FOOT PEDAL
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 Key14132549
MDR Text Key289430233
Report Number3010266064-2022-00300
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10026
Device Catalogue NumberROB10026
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
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

Patient Treatment Data
Date Received: 04/18/2022 Patient Sequence Number: 1
Treatment
ROB20000/CORI ROBOTICS USA/ SN (B)(4).
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