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

Model Number BUR4070DT

Device Problem Break (1069)

Patient Problem Hearing Impairment (1881)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced devices were not returned to olympus for evaluation and were discarded by the user facility after the procedure; therefore, no evaluation will be performed.Based on similar reports, the most likely cause of the reported event can be attributed excessive force.The bur4070dt instruction manual warns users ¿always use the system as outlined in this instruction manual.Improper use will not only impede functions and prevent optimum performance, but may cause equipment damage and / or complications.Before each use, always inspect the equipment as outlined in this instruction manual.".

Event Description

Olympus was informed that during a therapeutic functional endoscopic sinus surgery (fess) procedure, the tips from two burrs snapped off and fell into the patient¿s sinus.It was reported that while the surgeon was drilling in the patient¿s sinus the breakage occurred.Simultaneously, the surgeon noted a whirling and screeching noise from the device.The user facility reported that after each breakage the device fragments were retrieved utilizing suction.There was no unusual bleeding noted.A third similar device and new tubing were used to complete the intended procedure.There was no patient injury reported.However, it was reported that post procedure due to the grinding noises from the damaged device the surgeon experienced ringing in both ears for an extended period.There was no medical or surgical treatment required.Additionally, it was reported that the device was inspected prior to use with no anomalies found.This is report 1 of 2.

• Brand Name: BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK
• Type of Device: BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7341884
• MDR Text Key: 103148277
• Report Number: 2951238-2018-00182
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2018

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
• Device Operator: Health Professional
• Device Model Number: BUR4070DT
• Device Catalogue Number: BUR4070DT
• Device Lot Number: JC657883
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR