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

Catalog Number 220025

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

It was reported that during case entered into cutting, and as soon as the anspach foot pedal was engaged, an error appeared.Moved back to the bur/control selection stage.Recalibrated and rehomed, but the same thing happened when returning to cutting; tried a different handpiece, with the same results.The system was then restarted and everything proceeded as usual.

Manufacturer Narrative

The device was used in treatment and the log files were returned for investigation.Evaluation of the returned log files was performed which showed an "over current" error.When the error can only be cleared by rebooting the system, it is indicative of an issue in the siu firmware that randomly causes the handpiece error message and is not indicative of an issue with the handpiece.This confirms the issue in the siu.There was no serial number provided for the dhr review of the siu, and therefore it could not be concluded if the device met the manufacturing specifications.A complaint history review found 4 reports of the issue.This issue will continue to be monitored.The relationship of the device and the reported event has been established.The over current error that occurred was due to an issue in the siu.As a result, the root cause of the reported event was due to an 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: 9996817
• MDR Text Key: 188886199
• Report Number: 3010266064-2020-00150
• 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: 04/24/2020

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: No Information
• Device Catalogue Number: 220025
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1