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 Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

It was reported that, before a navio procedure, the camera would not connect during the hardware connection phase when launching a case.The busy circle kept spinning while both green lights on camera were solid.They did some troubleshooting and determine this camera will not connect to either machine.The other camera at facility had no problem connecting with both machines.No patient was involved at the moment.It was swapped for its backup to proceed without delays.No other complications were reported.

Manufacturer Narrative

H3, h6: the reported device, intended for use in treatment.Was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.A factor that may have contributed to the reported complaint include, 1) the device may have experienced component failure.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: 10711210
• MDR Text Key: 212282822
• Report Number: 3010266064-2020-01919
• 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: 07/12/2021

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CABLE, CAMERA CART, NAVIO.; CABLE, CAMERA CART, NAVIO