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

Catalog Number NPFS02070

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2020

Event Type  malfunction  

Event Description

It was reported that during a preventive maintenance, the fully charged unit was able to boot and run for 1.5 hrs with no issues.Upon shutdown and reboots the error code 2000000000000 was continually displayed.It was tried troubleshooting, charged for an extended period, changing ups/usb ports, checking trip switches, and changing the power sources.However, there was no improvement.No patient was involved.

Manufacturer Narrative

H3, h6: the navio surgical system au, part number npfs02070, serial (b)(6) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.The customer ups was connected to a known-good navio system and a 2040000000000 error was outputted on the screen.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 concluded this was an isolated event.The most probable cause of the reported problem is a failing ups battery cell.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.Additional information: d8/d9.

• Brand Name: NAVIO SURGICAL SYSTEM AU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10160624
• MDR Text Key: 195381368
• Report Number: 3010266064-2020-01599
• Device Sequence Number: 1
• Product Code: OLO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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 Catalogue Number: NPFS02070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Distributor Facility Aware Date: 05/19/2020
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1