MAUDE Adverse Event Report: GYRUS ACMI INC. BURR, 4.5MM, 15DEG, BALL BURR, 5/PK

Model Number BUR45151BB

Device Problems Thermal Decomposition of Device (1071); Charred (1086)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2014

Event Type  malfunction  

Event Description

The user facility reported that after 15 minutes of drilling a hard thick bone, smoke was noticed coming from the connection between the tubeset and the burr during an endoscopic sinus surgery.The tubeset and burr were disassembled and a charr mark or stain on the burr was observed.The physician replaced the tubeset and the burr and finished the procedure.There was no patient injury reported.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.If additional information or if the device is received at a later time this report will be supplemented.

• Brand Name: BURR, 4.5MM, 15DEG, BALL BURR, 5/PK
• Type of Device: BURR
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer (Section G): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3807239
• MDR Text Key: 4388935
• Report Number: 2951238-2014-00121
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BUR45151BB
• Device Catalogue Number: BUR45151BB
• Device Lot Number: IH806301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1