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 10/05/2020

Event Type  malfunction  

Event Description

It was reported that before a navio tka procedure, after initially calibrating a "re-initializing camera" message was prompted when the system said the camera became disconnected.They checked cable connections and after several minutes of waiting for hardware connection to reestablish without success, they proceeded to reboot the system in addition to re-connecting the cables.After multiple attempts of these steps without successful camera connection, they resorted to swapping the camera for the backup camera the hospital had in storage.The cases proceeded without further error messages.The delay was less than 30 minutes and no patient was harmed.No other complications were reported.

Manufacturer Narrative

H3, h6: the ndi camera polaris spectra, part number pfsr200027, serial (b)(6) and intended to be used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.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.If the product associated with this event is returned or provided 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: 10718006
• MDR Text Key: 212492537
• Report Number: 3010266064-2020-01934
• 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: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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?: No
• Date Manufacturer Received: 10/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CABLE, CAMERA CART, NAVIO/200028.; NAVIO SURGICAL SYSTEM US/NPFS02000. SERIAL:(B)(6)