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

Model Number XOM UNK BUR

Device Problem Vibration (1674)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

It was reported that the device wobbles.Additional information received that there is no impact on neither the patient nor the staff.Following troubleshooting was done by removing and installing bur, it was repeated a few times.It was not attempted to install the bur into other handpieces.

Manufacturer Narrative

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

• Brand Name: XPS® BUR - UNKNOWN
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; jacksonville
• Manufacturer (Section G): MEDTRONIC XOMED INC.; jacksonville
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 12861072
• MDR Text Key: 283477287
• Report Number: 1045254-2021-00647
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2021

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 UNK BUR
• Device Catalogue Number: XOM UNK BUR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1