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 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that there was no contact between cori and real intelligence tracking camera.They tested with other camera and it gave good result.As this happened in a non-surgical environment, there was not patient involvement.

Manufacturer Narrative

Results of investigation: the ri tracking camera, (belgium) part number rob10025, serial (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The ri tracking camera was connected.The right led light was blinking with an audible alert.Reset the shock sensor and functions.A relationship between the reported event and the device was confirmed.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 review of prior escalation actions found no actions applicable to the scope of this case.The most likely cause of this event is the power source (battery) to the shock sensor circuit has disconnected itself from the shock sensor circuit during camera transport resulting in the front camera leds blinking red and an audible beep.The camera is an oem product and cannot be disassembled further to arrive at a root cause.Refer to the cori users manual for transporting guidelines.Care and caution should be taken when moving cori over thresholds and bumps to avoid system damage.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 and trended through post market surveillance activities.

• 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: 12595315
• MDR Text Key: 277716426
• Report Number: 3010266064-2021-00710
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757437
• UDI-Public: 00885556757437
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

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
• Device Operator: Health Professional
• Device Model Number: ROB10025
• Device Catalogue Number: ROB10025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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
• Treatment: ROB20000-CORI ROBOTICS USA