BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25KHZ STRAIGHT TIP

    MDR report key: 3850668 · Received June 5, 2014

    Report

    Report Number
    0001811755-2014-02045
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 25KHZ STRAIGHT TIP WAS OVERHEATING CAUSING THE PLASTIC IRRIGATION SHIELD TO MELT ONTO THE TIP AT THE END OF A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330022 25KHZ STRAIGHT TIP INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-KALAMAZOO UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1