MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKING CAMERA ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10025

Device Problem Intermittent Communication Failure (4038)

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

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: case-(b)(4).

Event Description

It was reported that when they powered on the cori machine for a tka procedure and added the patient's information, an error massage saying "incompatible camera firmware" appeared. They switched off machine, switched it on again, went to admin and updated camera firmware again. They followed troubleshooting guide, switched off machine, unplugged and plugged back camera, foot pedal, ether-net cable, powered off, waited for 1 min, powered on again, turned camera facing the wall, and proceed again to case setting up, but the same "incompatible camera firmware" appeared. So, they quit, proceed to admin to update firmware again, went back to case and same "incompatible camera firmware" message appeared. Therefore, they informed surgeon that the machine was not ready and surgeon proceed with conventional manual procedure. No patient injury was reported. After the procedure was changed, the development manager repeated the steps listed above with same conditions and she was able to proceed to case creation and burr selection as per normal. No delay was reported. No other complications were reported.

• Brand Name: REAL INTELLIGENCE TRACKING CAMERA
• 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: 11528583
• MDR Text Key: 241025851
• Report Number: 3010266064-2021-00212
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757437
• UDI-Public: 00885556757437
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROB10025
• Device Catalogue Number: ROB10025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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: Reuse

Patient Treatment Data

Date Received: 03/19/2021 Patient Sequence Number: 1