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

Catalog Number PFSR200027

Device Problem Intermittent Communication Failure (4038)

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

Event Date 09/01/2020

Event Type  Injury  

Event Description

It was reported that before a navio procedure, they did some trouble shooting but could not get the camera to connect in time to do the case of the day.The procedure was changed to manual instruments.No other complications were reported.

Manufacturer Narrative

The reported device, used in treatment, was returned for evaluation.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.Nothing was identified visually that contributed to the reported problem.Functional evaluation found that the camera successfully completed the aak and functioned as expected.The camera event log was also evaluated and showed no signs of faults or errors.No problem found with the camera.The reported issue was most likely due to intermittent connections or improper setup.No containment or corrective actions are recommended at this time.Per complaint details, the device malfunctioned and the rep ¿could not get the camera to connect in time to do the case that day¿ after troubleshooting attempts.Responses to the requested documentation/clinical information were not provided as of the date of this assessment.Based on the information provided the impact beyond the aborted navio case could not be definitively determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.Our reference number: (b)(4).

• 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: 10621453
• MDR Text Key: 209629568
• Report Number: 3010266064-2020-01811
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 10/07/2020
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CABLE, CAMERA CART, NAVIO; CABLE, CAMERA CART, NAVIO
• Patient Outcome(s): Required Intervention