MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - HIGH SPEED RAD®; BUR, EAR, NOSE AND THROAT

Model Number 1883670HS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

The bur has not been returned for evaluation.

Event Description

The customer reported three high speed burs broke within thirty seconds after use during a procedure.This report represent bur 3 of 3.

• Brand Name: XPS® BUR - HIGH SPEED RAD®
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: angie demo ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328355
• MDR Report Key: 7148962
• MDR Text Key: 96018732
• Report Number: 1045254-2017-00495
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 20681490692810
• UDI-Public: 20681490692810
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/27/2017

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 Expiration Date: 08/01/2023
• Device Model Number: 1883670HS
• Device Catalogue Number: 1883670HS
• Device Lot Number: 0209944308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/27/2017
• Date Device Manufactured: 08/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1