BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25KHZ STRAIGHT TIP

    MDR report key: 2896492 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04103
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION, IT WAS CONFIRMED THAT THERE WAS THERMAL DAMAGE AT THE TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONOPET TIP MELTED DURING A PROCEDURE. THE NURSE DID NOT PRIME IRRIGATION TUBING AS INSTRUCTED IN THE IFU. 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 25KHZ STRAIGHT TIP LFL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK