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

Model Number XOM UNKNOWN BUR

Device Problems Misconnection (1399); Vibration (1674)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

There were 2 devices being used in this surgery, we are submitting 2 mdrs for the same event.This is same event as regulatory report 1045254-2021-00147 list of products involved: hand piece visao 3334800 80k, serial # (b)(4), lot# 206971783, unknown bur lot number: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider (hcp) reported that the bur was difficult to be installed in the handpiece but it seemed to be installed finally for use.However, wobbling occurred when used on the patient.There was no impact on neither the patient nor the staff.

• 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: david gustafson ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635149628
• MDR Report Key: 11602378
• MDR Text Key: 243654274
• Report Number: 1045254-2021-00148
• 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
• Type of Report: Initial
• Report Date: 04/01/2021

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 UNKNOWN BUR
• Device Catalogue Number: XOM UNKNOWN BUR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 04/01/2021
• 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