MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10024

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

It was reported that, when the surgeon was smart mapping the femur during a cori ukr procedure, the surgeon released his foot from the pedal and the system was still capturing movement from the point probe and therefore collecting unwanted data points.This error was recovered by pressing the "release to stop" button on the screen.The surgeon was then able to go back and recollect his bone mesh of the femur at which point the error was resolved.There was a delay of fewer than 30 minutes.No patient was harmed and no other complications were reported.

Manufacturer Narrative

G3, h2, h3, and h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.The case files were provided and the screenshots were reviewed.A trail of points coming off of the femur in the femur free collection screen confirmed the complaint.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.The most likely cause of the point collection occurring after the foot pedal is released is a known software bug that is under investigation by the software engineering team.No containment or correction is required at this time.D10: add concomitants.H6: code update.

• Brand Name: REAL INTELLIGENCE CORI
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10875949
• MDR Text Key: 217414211
• Report Number: 3010266064-2020-02027
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA/SN (B)(6)