MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02000

Device Problems Battery Problem (2885); No Apparent Adverse Event (3189); Intermittent Communication Failure (4038)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Event Description

It was reported that, before a navio ukr procedure, the screen would not boot up.They received two different errors on the screen (errcode = 2000000000000 and errcode = 1).They shut down navio as instructed on screen, powered up with navio unplugged then plugged back in when smith and nephew slash came on screen.After the reboot, they proceeded without delay.No other complications were reported.

Manufacturer Narrative

G3, h2, h3, and h6: the product, navio surgical system us, npfs02000, (b)(6) used for treatment was not returned for evaluation, however photos were provided for evaluation.A relationship between the reported event and the device was confirmed.Photo 1 shows error code 2000000000000 and photo 2 shows error code 1.A functional evaluation could not be performed because the product was not returned.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is a ups issue.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.H6: update codes.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10895233
• MDR Text Key: 217998195
• Report Number: 3010266064-2020-02030
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• 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: 10/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISOLATION TRANSFORMER/UPS, U.S. (PN 200029); ISOLATION TRANSFORMER/UPS, U.S. (PN 200029)