MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CAMERA, POLARIS VEGA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 200597

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

It was reported that, during a navio tka procedure, the message "infrared bulb of the camera is not working correctly, camera view could be affected." popped up.They hide the message and were able to finish the surgery without delays.No other complications were reported.

Manufacturer Narrative

The polaris vega camera, product 200597, sn (b)(6) used for treatment was not made available to the designated complaint unit for evaluation thus, visual inspection and functional testing could not be performed.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.A relationship between the reported event and the device could not be established as the product was not returned.Although the reported problem was not confirmed, a contributing factor may be component failure; 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.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 at a future date, this evaluation will be reopened for investigation.

• Brand Name: CAMERA, POLARIS VEGA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10911268
• MDR Text Key: 218506552
• Report Number: 3010266064-2020-02041
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200597
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1