MAUDE Adverse Event Report: MEDTRONIC XOMED, INC BUR 1883070HS 3PK FRONTAL FINESSE HI SPE; BUR, EAR, NOSE AND THROAT

Model Number 1883070HS

Device Problem Smoking (1585)

Patient Problem Burn, Thermal (2530)

Event Date 02/10/2014

Event Type  Injury  

Event Description

It was reported that the device was in use for about most 2-3 minutes when it was noted that the shaft was warm to the touch.It caused a thermal injury to the inside of the nose.The surgeon noticed that ¿it didn't sound right (when it was still in the nose)¿, removed it from the nose, and saw that there was a thermal injury to the nasal septum.The surgeon ran it again outside of the nose, to test if it still made the same noise; within 5 seconds of running the drill it made a high pitched whine, "snapped" and then smoked.The surgeon continued with the surgery with a new bur.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).The product has not been returned for analysis.Method: no testing methods performed.

• Brand Name: BUR 1883070HS 3PK FRONTAL FINESSE HI SPE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 3659760
• MDR Text Key: 20008636
• Report Number: 1045254-2014-00051
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/05/2014
• Supplement Dates Manufacturer Received: 02/11/2014
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00032 YR
• Patient Weight: 56