MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS BUR - UNKNOWN; BUR, EAR, NOSE AND THROAT

Device Problem Vibration (1674)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional (hcp) reported that the handpiece was not working properly during tympano-mastoidectomy.The cutting bur was occasionally seeming less stable at the distal end of the bur.The bur was removed and re-seated, the case was completed using the handpiece and bur.There was no delay with the procedure.There was no patient impact.

• Brand Name: XPS BUR - UNKNOWN
• 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: tricha miles ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635140379
• MDR Report Key: 10800488
• MDR Text Key: 215094199
• Report Number: 1045254-2020-00539
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• 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