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

Catalog Number	ROB10024
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case- (b)(4).
Event or Problem Description
It was reported that during a cori assisted tka surgery, an icon of person reading book was displayed on the real intelligence cori and the system was forced shutdown.The procedure was completed, with a non-significant delay, using the same device (reboot).Patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a cori assisted tka surgery, an icon of person reading book was displayed on the real intelligence cori and the system was forced shutdown.The procedure was completed, with a non-significant delay, using the same device (reboot).Patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
Results of investigation: the cori console, pn rob10024, (b)(6), used in treatment, was returned for evaluation.There were no visual or functional abnormalities related to the reported system shutdown.The log files were pulled from the console for the occurrence date of 25-jan-2022.The naviosystem log shows ceased logging after the user had completed flexion range collection, indicating an abrupt shutdown of the system, and confirming the reported complaint.The most likely cause of this system shutdown is a known software issue.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• Brand Name: REAL INTELLIGENCE CORI
• Common Device Name: ORTHOPEDIC 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 Key: 13532619
• Report Number: 3010266064-2022-00098
• Device Sequence Number: 5038385
• Product Code: OLO
• UDI-Device Identifier: 00885556780855
• UDI-Public: 885556780855
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown