MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CAMERA, POLARIS VEGA; 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 03/17/2021

Event Type  malfunction  

Event Description

It was reported that during the femur cutting stage of a navio procedure, the error "camera infrared failure" popped on the screen.The case was continued without any issues (no delays).No other complications were reported.

Manufacturer Narrative

H3, h6: the reported device (pn 200027 sn (b)(6), used in treatment, 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.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.

Manufacturer Narrative

H3, h6: the ndi camera polaris spectra, part number pfsr200027, serial (b)(6) used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The camera was connected to a navio system and a case created.The camera infrared failure error displayed.An event log review was completed.The reported problem was confirmed.The event log identified numerous illuminator current faults.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 historical capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The most likely cause is a failure of the internal infrared led board(s) of the camera.The camera is an oem product and cannot be disassembled further to arrive at a root cause.This failure is an identified failure mode within the risk assessment.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.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 2905 northwest blvd ste 40; plymouth, MN 55441 ; 5123913905
• MDR Report Key: 11646958
• MDR Text Key: 244850303
• Report Number: 3010266064-2021-00269
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2021
• 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: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1