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

Model Number	1884380EM
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
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 manufacturer representative reported that the blade had a severe wobble to it when they tried to use it during a functional endoscopic sinus surgery (fess).They tried re-seating the blade in the handpiece but it still wobbled and had too much movement to be used effectively.The manufacturer representative visually inspected the blade and it did not appear to be broken.They opened a new blade and it worked without issue.There was no delay in the procedure as a result of this event.The device was used on the patient.There was no patient injury.

• Brand Name: XPS SYSTEM NAVIGATED BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 12407025
• Report Number: 1045254-2021-00492
• Device Sequence Number: 17238721
• Product Code: EQJ
• UDI-Device Identifier: 00643169209367
• UDI-Public: 00643169209367
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0222564030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 76