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	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during set up for a cori lab, they encountered two real intelligence robotic drill that showed a critical drill error when a robotic drill diagnostics test was performed.It would not allow for the drills to be recognized by the system , and the real intelligence cori would give the system fault: critical error upon plugging the handpieces in.Neither of the handpieces would register when a case was made and the drills were plugged in to calibrate.They took the top of the cori unit off to ensure that the console was working properly and it was.They could not go forward with either of the drills.No case involved; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the cori console, pn rob10024, sn (b)(6), intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported event was confirmed visually and functionality.Two cables in the drill port located internally in the console are detached.This caused the drill to failed.When the drill was been tested, in the administrator screen, the message drill critical error was observed.When a case was try, time out error occurred and the drill console indicator started to blink.The most likely caused of this event is the wiring detachment caused the console to not be able to connect with the drill.The system read a communication error, and think it is the drill the one that is working incorrectly.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.

• 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: 13815983
• Report Number: 3010266064-2022-00194
• Device Sequence Number: 11283517
• Product Code: OLO
• UDI-Device Identifier: 00885556773673
• UDI-Public: 885556773673
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 02/24/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 07/13/2022
• 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