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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  malfunction  

Event Description

It was reported that, after a navio tka procedure was completed, it was found that the amber led on the camera was activated.The error "camera infrared lamp is not working properly.This may result in a limited field of view" was on screen.No patient was involved.No other complications were reported.

Manufacturer Narrative

H3, h6: the ndi polaris camera, used in treatment, was returned for evaluation.There was a relationship between the device and the reported event.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review concluded this was a repeat issue.Visual inspection of the device revealed no discrepancies that may have contributed to the reported problem.A functional evaluation was performed and the camera event log was evaluated.The event log indicates multiple illuminator faults between 10/31/2020 to 11/04/2021.The camera was unable to be tested as it was unable to connect to the calibration module.The complaint was confirmed.A factor that may have contributed to the reported complaint include: 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.G1 mdr reporting contact name and address and phone number.

• 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: 10845214
• MDR Text Key: 216567842
• Report Number: 3010266064-2020-02006
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Manufacturer Received: 11/01/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1