MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR200027

Device Problems Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

It was reported that during setup for a navio procedure, the screen had an error "camera infrared lamp is not working properly.This may result in a limited field of view." the amber steady light also activated on polaris camera.The procedure was continued with manual instruments.There was a delay of less than 30 minutes.No other complications were reported.

Manufacturer Narrative

The reported device (pn 200027 sn (b)(6) used in treatment, was returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the navio risk profile.The navio user's manual (500196) provides instruction for camera setup, operation and troubleshooting.A relationship, if any, between the subject device and the reported event could not be determined.Nothing was identified visually that contributed to the reported problem.Functional evaluation confirmed the reported event, the amber error led was illuminated.The camera event log was also evaluated and indicated multiple illuminator faults between (b)(6) 2020 and (b)(6) 2020.The illuminator fault means that the illuminator leds have gone bad.The illuminator leds on the camera can go bad over time with use and cause floating ""dead zones"" in the camera view.This problem is physical in nature in the camera only and it needs to be serviced.No containment or corrective actions are recommended at this time.The medical evaluation found that, per complaint details, the device malfunctioned with a camera error prior to use and the navio was abandoned for manual instrumentation to continue the case.Per correspondence, no further interventions were required due to the reported event and the surgeon was satisfied with the outcome.S+n has not received adequate patient specific information/ documentation to fully evaluate the root cause of the reported event.However, patient impact beyond the reported use of the manual instrumentation to conclude the procedure would not be anticipated as per the complaint and field report, no patient injury resulted from the backup or the 0-30 minute surgical delay and reportedly the patient is ¿ok¿.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.

• Brand Name: NDI CAMERA POLARIS SPECTRA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10564598
• MDR Text Key: 207893679
• Report Number: 3010266064-2020-01787
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other