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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  Injury  

Event Description

It was reported that before a navio procedure, during the pre-op registration of camera and foot pedals, the warning "camera infrared lamp is not working properly.This may result in limited field of view" was displayed.They changed to manual procedure to complete the surgery.No other complications were reported.

Manufacturer Narrative

The reported device (pn 200027 sn (b)(6)) was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the navio risk profile.The navio user's manual (500196) provides instruction for camera setup, operation and troubleshooting.A relationship, if any, between the subject device and the reported event could not be determined.The reported error message indicates that the illuminator leds have gone bad.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: 11479017
• MDR Text Key: 239690173
• Report Number: 3010266064-2021-00187
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/14/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention