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

Model Number ROB10024

Device Problems Fitting Problem (2183); Unintended Application Program Shut Down (4032)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that when inserting the bur during the setup phase during a cori assisted ukr surgery, a system time out (the robotic drill has been deactivated) message prompted after pressing the ¿unlock¿ button (b)(4).Multiple attempts to recover were conducted including pressing ¿continue¿, ¿quit¿ and exiting out of the case and resuming the case.They disconnected the drill multiple times and had an equipment swap with two drills.The same error messages continued to persist and a full reboot of the system was conducted with no resolution (b)(4).A "communication failure" message and an internal error (the system has detected the application unexpectedly exited) were prompted (b)(4).They presumed that there was a connection problem associated with the console.So they borrowed a new cori console and tray from a nearby facility.They plugged in two of the previous "bad drills" into the brand new console and the error message still prompted.Therefore, the issue was caused by the drills and not the console (b)(4).To recover they used a new drill from a different facility and plugged that in to the new console and they were able to proceed with the case.The procedure was completed with a delay of over one hour with the patient under anesthesia and open on the table by using the s+n back-up device.The outcome of the patient¿s surgery was successful and there was no harm to the patient due to this error.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: sn000120 used for treatment was not returned to the designated complaint unit for evaluation.Although the product was not returned the software files were downloaded from the device and provided for investigation.The system time out error was confirmed during bur loading.However, the necessary logs (naviosystem.Log and xsession.Log) to further identify the cause were not provided.Although the cause of the error was not identified, factors that may have contributed to the reported issue may have been associated with the drill or the software.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
• Type of Device: 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: 12544108
• MDR Text Key: 273803824
• Report Number: 3010266064-2021-00682
• 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: K193120
• 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
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• 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: Unknown
• Patient Sequence Number: 1