MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI

Model Number ROB10024

Device Problems Application Program Problem: Parameter Calculation Error (1449); Unintended Application Program Shut Down (4032)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2021

Event Type  malfunction  

Event Description

It was reported that, during a training session with cori system, a multitude of errors were experienced: drill disconnect errors, which appeared to be due to overuse or overheating and the bur became stuck inside the drill and attachment could not be removed to remove the handpiece tracker; a back slap was used to disengage the bur and the pieces were removed and used on the other handpiece (b)(4); the other drill stopped working and the system had to be restarted entirely (b)(4).Also, there was a tibial bone model generation error, which was bypassed by removing a few points before continuing; a critical error notification; and a bad console notification; while entering a new case, the system shut down and the blue man appeared so a reboot was required (b)(4).As this event happened during a demo, no patient was involved.This was the third event of three.

Manufacturer Narrative

H3, h6: the ri cori (us), rob10024, (b)(6) intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.The software version was not recorded, but dhr review shows that all cori software versions released to the field have been validated.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with a software issue.This failure is an identified failure mode within the risk assessment.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) intended for use for treatment was returned to the designated complaint unit for evaluation.A visual inspection and functional evaluation were done on the console.There were no visual or functional non-conformances related to the reported events identified.The software files were downloaded from the device and provided for investigation.The complaint reports that a multitude of errors were experienced over the course of three days.The complaint date was recorded on 25-april-2021, so the log files occurring on the 23rd, 24th and 25th of april 2021 were reviewed.The reported ¿bone model generation error¿ was confirmed.This is an occurrence of a known software issue that has been corrected and released in cori-v1.4.3 software.The reported ¿critical error¿ was confirmed to occur when the user created a new case.This is an occurrence of a known software issue.The reported ¿system console is bad¿ error message was confirmed.Log file review found that there was a software-related issue resulting in the ¿system console is bad¿ error message that was an expected behavior of the system.The reported shut down of the system when entering a case and the ¿blue man¿ appearing on the console could not be confirmed.The log file review indicates that all system shutdowns had been ¿quit¿ by the user and the system exited the case correctly.It is possible that this may have occurred prior to the system starting the case and the shutdown would not have been logged.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 found related actions that are applicable to the scope of the reported complaint.No further action is required at this time.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
• Type of Device: REAL INTELLIGENCE CORI
• 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: 11861786
• MDR Text Key: 251949365
• Report Number: 3010266064-2021-00402
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2023
• 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: A
• Patient Sequence Number: 1