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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 Application Program Problem: Parameter Calculation Error (1449)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
It was reported that during a cori assisted tka surgery, surgeon said it looked like it was airballing even though they were two clicks into the notch warning. Surgeon was painting thoroughly on the anterior cortex both medially and laterally directly with the tip of the point probe (he might have been a bit posterior on his tibial point collection). The procedure was completed, without delay, using the same device. There was not any additional or unintended cuts performed (cuts were to plan). Patient was not harmed as consequence of this problem.
 
Manufacturer Narrative
Internal complaint reference: case(b)(4).
 
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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 Key14007488
MDR Text Key288589299
Report Number3010266064-2022-00248
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,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
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 Received03/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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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