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 Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2020

Event Type  malfunction  

Event Description

It was reported that during a lab/demo of a tka procedure, when they started the navio, a camera error came up that said infrared light needed to be replaced.They were unable to continue so they grabbed the camera from the hospital and switched out the navio system because the camera cord on the new ndi camera was not compatible with the plug on the side of navio.There was a delay of less than 30 minutes.No other complications were reported.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent 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 concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.A factor that may have contributed to the reported complaint include, 1) 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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 10399403
• MDR Text Key: 202812344
• Report Number: 3010266064-2020-01709
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1