MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SIU; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02000

Device Problems Circuit Failure (1089); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  malfunction  

Event Description

It was reported that during start up of the machine before a surgery, the screen displayed the following message with each start: "an error occurred during initialization: internal power system comm connection error.(errcode=4)".The equipment was swapped to continue with the procedure without delays.No other complications were reported.

Manufacturer Narrative

G3, h2, h3, and h6: the navio surgical system us, pn: ornpfs02000, (b)(6) intended for use in treatment was not returned to the designated complaint unit for evaluation.The navio surgical system log files and/or case files were not provided, either.Therefore, visual and functional inspections and log/case file assessments could not be performed, and the reported problem could not be confirmed.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.The reported complaint describes the system having incurred an internal power system communication connection error (errcode=4) during initialization.Although the reported problem was not confirmed, a contributing factor to this error could be an improper usb connection between the ups and the computer, or an intermittent usb cable.To resolve this error, it is suggested to shut down the navio system and unplug the ups from the wall.With the ups unplugged, boot up the system.Once the system reaches the splash screen, the ups can be plugged in to the wall.This error is likely avoidable when the ups is fully charged, and ensuring the ups is replaced every 2 years.No containment or corrective actions are recommended at this time.If the system log or case log associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO SIU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10198017
• MDR Text Key: 196929792
• Report Number: 3010266064-2020-01611
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NAVIO SURGICAL SYSTEM US