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

Model Number ROB10024

Device Problem Computer Operating System Problem (2898)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that while installation operations the new real intelligence cori would not boot up.Received nmh error.Tried to upload software twice but got error that firmware not able to install and cannot open port.As this was noticed in a non-surgical environment, there was not any patient involved.

Manufacturer Narrative

H3, h6: the real intelligence cori, part number rob10024, serial number (b)(6), intended for use in treatment, was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was confirmed with a functional evaluation.The console would not boot and then unknown nhm error was observed.The cori console was opened up and it was found that the irrigation pump motor had broken free from the front panel due to one of the screws holding it there being unseated.The motor had unplugged one of the connections between the cpu and tcu boards.When the motor was removed and the connection reestablished, the software and idb could be installed and the system boots up as expected.A relationship between the reported event and the device was established.The most likely cause of this event is one of the screws holding the motor to the front panel not being fully tightened at service.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 review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• 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: 16327175
• MDR Text Key: 309128471
• Report Number: 3010266064-2023-00022
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 03/21/2023
• 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