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

Model Number 31151098E

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available as of the date of this report.  a follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional (hcp) reported via a manufacturer representative that the tip of the bur snapped off and was left in the patients middle ear during a cochlear implant procedure.The hcp left the broken tip as it would be too dangerous for the other structures.The procedure was completed without the use of a back-up device.The procedure was delayed for 60 minutes due to the need for xray confirmation.The broken tip was confirmed to still be in the middle ear via xray.

Manufacturer Narrative

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

Event Description

Additional information from the healthcare professional (hcp) reported there has been no symptoms associated with the piece of the bur that remained inside the patient's middle ear.

Manufacturer Narrative

Analysis found that visually, the tip had broken off.The portion that became detached was not returned however it would have measured approximately 0.12¿ x 0.04¿.When viewed under magnification, the configuration of the fracture was consistent with shear or bending stress.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR
• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8110369
• MDR Text Key: 128584831
• Report Number: 1045254-2018-00659
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074322162
• UDI-Public: 00885074322162
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: 31151098E
• Device Catalogue Number: 31151098E
• Device Lot Number: 0215072934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 12/12/2018; 03/12/2019
• Supplement Dates FDA Received: 01/10/2019; 04/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention