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); Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

Event Type  malfunction  

Event Description

It was reported that during a lab/demo the camera would not read the handpiece or probe.An infrared warning came on at calibration.After troubleshooting, rebooting and changing the flat markers, it was concluded that the camera must not be working.The navio couldn't be used for the lab.No other complications were reported.

Manufacturer Narrative

The device intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.Functional evaluation was performed.The reported problem was confirmed.The camera illuminator failure error occurred while attempting an aak assessment.The camera event log was evaluated.The reported complaint was confirmed.The event log confirms illuminator fault errors.The camera was connected to a system and case (cut mode) for 4 hours.The reported problem was confirmed.The camera would not detect the handpiece.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 and failure mode(s) "doesn't work" identified similar events.The most likely cause of this event is a mechanical or electrical failure of the camera.The camera is an oem part and cannot be further disassembled to arrive at a root cause.No further 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: 10014020
• MDR Text Key: 189486960
• Report Number: 3010266064-2020-01555
• Device Sequence Number: 1
• Product Code: OLO
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• 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?: Yes
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1