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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2020
Event Type  malfunction  
Event Description
It was reported that, during a cori tka procedure, when unplugging the drill from the console, the screen went black and gave an "internal error" on the case information screen. They dismissed the error and pressed resume operation. This then took them through the calibration phase and then it took us to the "planning screen". Since the problem could not be solved, they switched the drill for its backup to move forward with the case. There was a delay of fewer than 30 minutes. No other complications were reported.
 
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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 Key10875886
MDR Text Key217424451
Report Number3010266064-2020-02026
Device Sequence Number1
Product Code OLO
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 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
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 Received11/23/2021
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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