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

Catalog Number PFSR200027

Device Problem Calibration Problem (2890)

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

Event Date 09/03/2019

Event Type  Injury  

Event Description

It was reported that, during an unspecified surgery, while the machine was being set-up, the handpiece calibration step was not getting passed: the handpiece and pointer indicators on screen were blinking continuously, indicating optics issue.The surgeon replaced trackers with fresh ones and cleaned the lens of camera, but the issue was not resolved.The navio case was aborted and the surgery was finished with manual instruments.The patient outcome is unknown.

Manufacturer Narrative

H11: corrected data in d10.Results of investigation: the device, used in treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established as the reported problem was not confirmed.A complaint history review found 5 (five) 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.This failure is an identified failure mode within the risk assessment.The surgical user's manual released at the time of the complaint (b)(4) provides instructions for the user in the " troubleshooting information¿ section: "camera error system message: camera infrared lamp is not working properly.This may result in a limited field of view.-you may choose to quit the intraoperative procedure or continue.If you choose to continue, the camera will continue to still function, however, the camera may have limited visibility." accordingly, product labeling has been ruled out as a cause of the complaint.The performed clinical / medical investigation indicates: "without supporting clinical/medical documents, a thorough investigation cannot be performed.¿ the subject device was not made available to the designated complaint unit for evaluation and thus visual and functional inspection could not be performed.A factor that could have contributed to the reported issue is if there was an issue with the illuminator leds on the camera.They can go bad over time and cause floating "dead zones" in the camera view.The root cause was established to be undetermined after 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: 9999291
• MDR Text Key: 189177060
• Report Number: 3010266064-2020-01397
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention