BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 2844871 · Received November 2, 2012

    Report

    Report Number
    1811755-2012-03986
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SONOPET UNIVERSAL HANDPIECE WAS BEING USED DURING A PROCEDURE WHEN THREE SONOPET TIPS USED ALONG WITH THE HANDPIECE MELTED. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAY IN THE PROCEDURE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL HANDPIECE LFL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B)(4)| THE 3 TIPS MELTED: 5450800307 (LOT# 0088510)