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

Model Number XOM UNKNOWN BUR

Device Problems Failure to Power Up (1476); Vibration (1674)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider (hcp) reported that a bur attached to the handpiece has poor rotation and bur wobbles during the procedure.Even using a new bur same issue.There was no patient/staff 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: 10243530
• MDR Text Key: 197937540
• Report Number: 1045254-2020-00303
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/08/2020

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: XOM UNKNOWN BUR
• Device Catalogue Number: XOM UNKNOWN BUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/08/2020
• 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