MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK

Model Number BUR4070DT

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.However, if additional information becomes available or if the device is returned for evaluation at a later date, this report will be supplemented accordingly.

Event Description

The manufacturer was informed that during a functional endoscopic sinus surgery, smoke was observed and the 4mm diamond taper burr at the distal tip was found burnt.The burr tip was replaced and the procedure was completed using another burr.There was no patient injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 2951238-2020-00385.The customer returned the subject bur4070dt and reported while using the burr to cut bones during the fess procedure, smoke came out.The inner burr was apparently damaged by a direct contact with the outer tube.This could happen due to user¿s inadequate handling, such as pushing the tilted burr too hard against an object.Smoking was likely attributed to friction of the burr spinning at high speed.Due to an unknown lot number, a review of the device history records (dhr) review not be conducted, however, if the lot number becomes available at a later date, this report will be supplemented accordingly.Olympus will continue to monitor complaints for this device.Per the diego elite ifu, the blade should be carefully distant from everything and not be in contact with metal or any unintended tissue during activation.Furthermore, output power should be as low as possible, excessive generator output time may result in burning tissue or damage to the device.

• Brand Name: BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK
• Type of Device: BURR, 4MM, 70DEG, DIAMOND TAPER
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9873530
• MDR Text Key: 184708318
• Report Number: 2951238-2020-00385
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-EQJ
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BUR4070DT
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSOLE: S/N: (B)(4); CONSOLE: S/N: (B)(4)
• Patient Age: 36 YR