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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10024
Device Problem Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2022
Event Type  malfunction  
Event Description
It was reported that, during set up for a cori assisted tka surgery, it was noticed that the real intelligence robotic drill was not programmed correctly. After opening a case, they could not advance to calibrate drill or begin a case as an internal error continued to display after each attempt. The kpc screen showed that the drill date was not calibrated correctly. The procedure was finished with a smith and nephew back up device without significant delays. The patient was not harmed.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand NameREAL INTELLIGENCE CORI
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 Key14947115
MDR Text Key295436019
Report Number3010266064-2022-00518
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10024
Device Catalogue NumberROB10024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2022
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 Reuse

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