MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK

Model Number	BUR3070DB
Medical Device Problem Codes	Melted (1385); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The subject device was discarded by the user, and therefore a root cause could not be determined.Probable cause is the damage was incurred during transportation or use.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that during a fess (functional endoscopic sinus surgery) procedure, the gears within the handpiece of the device that connect to the burr were disintegrated/melted (as described by the reporter) during use.According to the reporter there was no damage to the handpiece or the gear that drives the blade mechanism.The plastic that melted was at the point where the blade interlocks with the mechanism of the tube set.The handpiece along with the tube set were replaced and the intended procedure was completed with no issue.There was no patient harm or injury reported on this event.No user harm was reported.

• Brand Name: BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK
• Common Device Name: BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10431081
• Report Number: 1037007-2020-00034
• Device Sequence Number: 19375961
• Product Code: GEI
• UDI-Device Identifier: 00821925027961
• UDI-Public: (01)00821925027961
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT-EQJ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BUR3070DB
• Device Lot Number: AV912844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1