BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS BLADE

    MDR report key: 11902069 · Received May 28, 2021

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    Report

    Report Number
    1045254-2021-00263
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 28, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00681490613286
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 WOBBLED/VIBRATED SEVERELY WHEN BEING USED IN THE PATIENT DURING THE INFERIOR TURBINATE REDUCTION PROCEDURE. THEY CHANGED OUT THE BLADE AS PART OF THE TROUBLESHOOTING STEPS. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THERE WAS A 5 MINUTES DELAY WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799451 XPS BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882040 0221853309 00681490613286

    Patients

    Seq Age Sex Outcome Treatment
    1