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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 Unintended Application Program Shut Down (4032)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2020
Event Type  malfunction  
Event Description
It was reported that during cori tka procedure while mapping the femur the cori crashed. Surgeon had to turn the power off on the back of the unit, reboot, and restart the case from the beginning. The surgeon proceeded to prepare his patella while cori rebooted. The procedure was completed with the same device. Surgeon was delayed no more than 30 minutes because he had to start at beginning of work flow. No injury to patient.
 
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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
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
7634524980
MDR Report Key10701374
MDR Text Key212075346
Report Number3010266064-2020-01892
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757420
UDI-Public00885556757420
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
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 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2020
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 Received11/16/2021
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 Reuse

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