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

Model Number 1884380EM

Device Problem Vibration (1674)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event 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
• 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: 12407025
• MDR Text Key: 269464738
• Report Number: 1045254-2021-00492
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00643169209367
• UDI-Public: 00643169209367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• Date Device Manufactured: 07/09/2021
• 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
• Patient Age: 32 YR
• Patient Weight: 76