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 Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2020

Event Type  Injury  

Event Description

It was reported that, during unknown navio procedure, while patient under anesthesia during machine setup for the case it was found that the error led is activated.Also the error " camera infrared lamp has failed.This may result in limited field of view".Delay reported less than 30 minutes for the procedure was completed manually.

Manufacturer Narrative

H3, h6: the reported device (pn: 200027, sn: (b)(6), used for treatment, was returned for investigation.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 be determined.Functional evaluation confirmed the issue.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.The medical investigation found that per complaint details, the device malfunctioned during setup for the procedure during which the patient was anesthetized; therefore, the procedure was abandoned for manual instrumentation resulting in less than a 30 minute surgical extension.It was communicated that the requested clinical documentation/ information was not available for inclusion in the medical investigation.Based on the information provided, patient impact beyond the reported modified procedure and the 0-30 minute surgical delay would not be anticipated as no patient injury was alleged, no additional interventions were required due to the reported event, and it was communicated that the patient was ¿ok¿.No further medical assessment is warranted at this time.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.

• 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: 10711922
• MDR Text Key: 212303740
• Report Number: 3010266064-2020-01927
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention