BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS BLADE

    MDR report key: 11806284 · Received May 11, 2021

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    Report

    Report Number
    1045254-2021-00239
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 11, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE WAS VIBRATING EXCESSIVELY IN THE HANDPIECE DURING THE PROCEDURE. IT WAS NOTED THAT THE HCP USED OUR SHAVERS HUNDREDS OF TIMES AND KNOWS HOW TO TROUBLESHOOT. WHEN THE HCP RESEATED THE BLADE, THE PROBLEM DID NOT GO AWAY. THE HCP ENDED UP NOT USING THE HANDPIECE AND JUST GRABBED ANOTHER ONE AND STARTED THE CASE WITHOUT ANY ISSUES OR DELAYS. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT OCCURRED WHEN HANDPIECE WAS BEING USED ON A PATIENT DURING THE PROCEDURE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703849 XPS BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882940 NO INFORMATION

    Patients

    Seq Age Sex Outcome Treatment
    1