MAUDE Adverse Event Report: COVIDIEN LLC XPS BUR; BUR, EAR, NOSE AND THROAT

Model Number 1885061HS

Device Problem Break (1069)

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

Event Date 07/05/2021

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 via manufacturer representative that the tip of the bur broke but not detached while being used on a patient and stuck in the handpiece during the functional endoscopic sinus surgery procedure.The broken parts were contained in the outer blade.There was no fragments that came off or got detached from the broken device.There were no fragments that that get in contact with the patient.There was no broken pieces of the reported product remain inside the patient's body.There was no intervention planned or performed.There was no broken pieces of the reported product remain inside the patient's body.There was no back-up device used.The case was completed by using other instruments instead of the burr.There was no patient impact.

• Brand Name: XPS BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: david gustafson ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635149628
• MDR Report Key: 12273435
• MDR Text Key: 264924303
• Report Number: 9612501-2021-01282
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00681490693066
• UDI-Public: 00681490693066
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1885061HS
• Device Catalogue Number: 1885061HS
• Device Lot Number: 0221275014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2021
• Date Device Manufactured: 12/01/2020
• 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