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

Catalog Number NPFS02000

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/16/2015

Event Type  malfunction  

Event Description

It was reported that during a test, the user plugged the ups end of the cpu to ups, and the usb cable into the + 12 volt side of the external ups power connection.After the large fire-ball, the ups shut off immediately.The usb connection on the cpu was welded to the cpu and cannot be removed yet the 'service' system still functions.The user was trying to simulate a clinical rep scenario to minimizing the possibility of this occurring in the field.No patient was involved and there was no injury to the user.

Manufacturer Narrative

H10 h3, h6: the device was intended for use in treatment and was returned for investigation.Investigation found that the service manager was simulating a possible mistake that could be made by a service rep.The cpu to ups usb cable connection on the ups is close to the battery extension terminals on the back of the ups.These terminals are exposed and being close to the usb connector, the service manager wanted to see what would happen if a service tech accidentally put the connector into one of the exposed terminal openings.When the connector was put into the + terminal (36vdc, 50 amps), what was described as a large fireball was produced and the usb cable was welded to the computer on the other end of the cable.A cover for the battery terminals that will snap into place based off of an off the shelf dust cover was designed to prevent future occurrences.The probable cause of the issue was design specification insufficient.The software version noted in the initial investigation documents was not identified in the dhr so we are unable to conduct a dhr review as a part of the investigation.A complaint history review found no other similar reports as this was the only complaint.A relationship between the device and the reported event could be established.

• 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: 9984533
• MDR Text Key: 188668119
• Report Number: 3010266064-2020-00268
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• 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?: Yes
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1