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

Model Number	1885061HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 12273435
• Report Number: 9612501-2021-01282
• Device Sequence Number: 19957084
• Product Code: EQJ
• UDI-Device Identifier: 00681490693066
• UDI-Public: 00681490693066
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1885061HS
• Device Catalogue Number: 1885061HS
• Device Lot Number: 0221275014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1