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

Catalog Number PFSR200027

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2020

Event Type  malfunction  

Event Description

It was reported that when starting a navio tka case during an internal training, the camera was working normally and would beep like it was connected, but the screen where you plug in to the camera would not register.The front cover was removed and manually re-plugged the camera cord into the unit.The camera connected but an error message came up during calibration "camera infared lamp is not working correctly".They dismissed the error but the camera could not track the handpiece or trackers and the light on the right had now turned orange.No patient was involved.No other complications were reported.

Manufacturer Narrative

The navio camera intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The evaluation followed pv0002 rev c.The aak assessment could not be completed.The camera error led was present when camera was plugged in.The camera event log was evaluated.The event log shows multiple signs of illuminator faults and bump sensor errors.The reported problem 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 associated with the part with the failure modes ¿display or visual feedback problem¿ and "system hardware fault" and "functional - system hardware fault" identified similar events.The most likely cause of this event is an electrical failure of the illuminator board.The camera is an oem part and cannot be further disassembled to arrive at a root cause.No containment or corrective actions are recommended at this time.

• 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: 10552199
• MDR Text Key: 207520880
• Report Number: 3010266064-2020-01775
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• 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: 10/07/2020
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1