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

Model Number NPFS02000

Device Problem Overheating of Device (1437)

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

Event Date 11/07/2019

Event Type  malfunction  

Event Description

It was reported that a camera infrared warning sign came up before starting the lab.No case involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established as the reported problem was confirmed.A complaint history review found 11 (eleven) similar reports, this issue will continue to be monitored.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.Visual inspection found that the camera displays numerous scratched and smudges covering most of the outer case.A functional evaluation was performed.Review of the event logs revealed a considerable number of 'illuminator current lower than recommended errors' between (b)(6) 2019 and (b)(6) 2019.Upon connection to ndi accuracy assessment kit to evaluate the camera accuracy, the camera error led was illuminated.Upon connection to the ndi configure app the 'illuminator hardware' error was displayed.The camera was connected to a navio system at the 'femur bone removal' screen.Following the warm up period, the camera error led illuminated and the "infrared lamp was not working properly.This may result in a limited field of view." error was displayed confirming the issue observed by the user.The root cause was established to be supplier / raw material fault.No containment or corrective actions are recommended at this time.

• Brand Name: 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: 9999255
• MDR Text Key: 189186799
• Report Number: 3010266064-2020-01385
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

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 Model Number: NPFS02000
• Device Catalogue Number: 200027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 04/25/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1