MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SIU - SOFTWARE INTERFACE UNIT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 220025

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2019

Event Type  malfunction  

Event Description

It was reported that navio surgical system continuously displays hardware error message (errcode = 40000000000) during demo.Inspected the unit and found that the siu was not functioning according to specification.Demo was completed as a manual procedure.

Manufacturer Narrative

H10: the device, intended to be used during treatment, was returned for a prior investigation.The functional inspection of the returned siu found that the device received a 41800000000-error message when powered on.This was indicative of fuse damage.The inspection procedure document was reviewed for the device at the time of manufacturing and passed all tests.Therefore, the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found similar reports of the issue.This issue will continue to be monitored.The relationship of the device and the reported event has been established.The error message was caused by a faulty cable in the handpiece which is causing the fuse in the siu to blow.The root cause of the reported event was due to electrical component failure.We are further investigating this issue and a corrective action has been opened.

• Brand Name: SIU - SOFTWARE INTERFACE UNIT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2828 liberty ave; suite 100; pittsburgh, pa
• MDR Report Key: 9998664
• MDR Text Key: 189503126
• Report Number: 3010266064-2020-01068
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 220025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1