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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10013
Device Problems Overheating of Device (1437); Noise, Audible (3273); Key or Button Unresponsive/not Working (4063)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that, during a cori assisted surgery, they heard unusual noises from the real intelligence robotic drill, and then it stopped working. Also, the wiper detached from the ri robotic drill attachment, and it was moving through the bur. The procedure was completed with manual instrumentation with a delay greater than 30 minutes. The patient was not harmed beyond the reported problem.
 
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Brand NameREAL INTELLIGENCE ROBOTIC DRILL
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 Key13087638
MDR Text Key282774907
Report Number3010266064-2021-00904
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K201022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROB10013
Device Catalogue NumberROB10013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
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

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