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

Model Number NPFS02000

Device Problem Output Problem (3005)

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

Event Date 01/13/2020

Event Type  malfunction  

Event Description

It was reported that, after installing 1.Application 2.Idb 3.Language pack in navio software to a brand newly delivered system, the system was rebooted following that process and went back to calibrate the monitor.After this, the system was shut down from the navio start screen.With the system down, plugged the camera and both foot pedals in their respective spots.Then started the system and waited for the system to go through integrity tests and presented an error: "an error occurred during initialization: internal power system comm connection error.(errcode = 400000004)." rebooted the system 2 times and the same error kept appearing.Finally, after shutting down again, unplugged the power cord and turn the system back on.With the power cord unplugged still, waited until the sn splash screen appeared and quickly plugged the power cord back in and the problem was resolved.No patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A complaint history review found similar reports, this issue will continue to be monitored.Dhr review found that this software version (rc-7007) has been validated on tr1614.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.A factor that could have contributed to the reported issue is if there was a connection issue with the ups or if it was not fully charged.

• 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
• MDR Report Key: 9999402
• MDR Text Key: 189062392
• Report Number: 3010266064-2020-01427
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 08/09/2020
• Supplement Dates FDA Received: 08/15/2020
• Patient Sequence Number: 1