MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SIU; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 220025

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2018

Event Type  malfunction  

Event Description

It was reported that when booting up system for a demo, following error displayed: "an error occurred during initialization: pfs control hardware failure.Errcode = 40000000000".

Manufacturer Narrative

H10: the device, intended to be used during treatment, was returned for a prior investigation.The initial functional inspection of the returned siu found that the device received a 40000000000-error message when powered on.This was indicative of a blown fuse.The dhr was reviewed for the device at the time of manufacturing and was found to meet manufacturing specifications prior to release for distribution.A complaint history review found 13 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 40000000000 error code that appeared confirms a blown fuse in the siu.Some factors that may contribute to the blown fuse in the siu include damage to the handpiece cabling by the user pulling on the strain relief or by normal wear and tear of the cabling.However, there were no problems found with the returned handpieces.The root cause of the reported event was due to electrical component failure.

• Brand Name: SIU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993903
• MDR Text Key: 189758868
• Report Number: 3010266064-2020-00805
• 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
• 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: 04/23/2020
• 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: 09/10/2018
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1