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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 Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Event Description
It was reported that, during a cori-assisted ukr surgery, and when setting up the robotic drill in the robotic drill diagnostic screen and after pressing unlock to insert the bur, the drill did not allow the tech to fully seat the bur through the long attachment ((b)(4) and (b)(4)). Normally the tech is able to feel two clicks after inserting the bur before pressing lock. These steps were performed multiple times before deciding to enter the case and unlock the bur from the case. After pressing unlock the system prompted with a system fault error message stating there was a communication failure and to call robotic support. The robotic drill was disconnected, reinserted and the error continued to occur. A full reboot of the system was conducted and the error still prompted ((b)(4)). The procedure was finished with smith and nephew back up devices after a significant delay (more than 30 minutes). The patient was not harmed.
 
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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 Key12125425
MDR Text Key260581187
Report Number3010266064-2021-00517
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757420
UDI-Public00885556757420
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,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
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 Received07/07/2022
Was Device Evaluated by Manufacturer? No
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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