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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10015
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that during set up for a cori assisted surgery, the real intelligence cori was used to create a case, they plugged the drill in and immediately received a critical internal error ((b)(4)). They were unable to quit the case so they proceeded to shut down the unit via the power switch in the back. Then they realized that the ri robotic drill attachment had gotten jammed in the real intelligence robotic drill ((b)(4)). They attempted to unlock the ri robotic drill attachment by using the robotic drill diagnostic application and also by creating a test case neither method were successful ((b)(4)). They didn¿t have any other trays available, so the surgeon did the case with standard instrumentation. The procedure was completed, with a non-significant delay, by changing in surgical technique. Patient was not harmed beyond the problem reported.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that during set up for a cori assisted surgery, the real intelligence cori was used to create a case, they plugged the drill in and immediately received a critical internal error ((b)(4)). They were unable to quit the case so they proceeded to shut down the unit via the power switch in the back. Then they realized that the ri robotic drill attachment had gotten jammed in the real intelligence robotic drill ((b)(4)). They attempted to unlock the ri robotic drill attachment by using the robotic drill diagnostic application and also by creating a test case neither method were successful ((b)(4)). They didn¿t have any other trays available, so the surgeon did the case with standard instrumentation. The procedure was completed, with a non-significant delay, by changing in surgical technique. Patient was not harmed beyond the problem reported.
 
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Brand NameRI ROBOTIC DRILL ATTACHMENT
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 Key12912259
MDR Text Key285222150
Report Number3010266064-2021-00837
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROB10015
Device Catalogue NumberROB10015
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2022
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 Unkown

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