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

Model Number	PFSDV0016
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cori tka procedure, they received a camera disconnection error just after the arrays were put in and were about to begin registration.They recovered by hitting the continue button.The camera re-initialized and there was no need to re-boot and re-calibrate.The procedure was successfully completed as planned with cori.There was a delay of less than 30 minutes and no impact to the patient.No other complications were reported.
Additional Manufacturer Narrative
The real intelligence tracking camera, part number rob10025, serial (b)(6) and used for treatment, was not returned for evaluation.A relationship between the reported event and the device was established.A visual/functional inspection cannot be completed as no device was returned for evaluation.Review of the patient screenshots confirms the customer reported problem of "camera disconnected" error.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.The most probable cause of the reported problem is a loose/no connection between console and the camera.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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: REAL INTELLIGENCE TRACKING CAMERA
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10437945
• Report Number: 3010266064-2020-01729
• Device Sequence Number: 16847971
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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 Model Number: PFSDV0016
• Device Catalogue Number: ROB10025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1