BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOPET DISPOSABLE TUBING SET AND EXTENDER FILTER TUBING

    MDR report key: 3261577 · Received July 29, 2013

    Report

    Report Number
    3261577
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS,DIV OF STRYKER CORP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    NOTED PLASTIC SHEET AROUND THE SONOPET TIP WAS MELTED; MELTED COMPONENT WAS ABOUT 1 INCH LONG FROM TIP AND LOCATED ON THE BOTTOM (OR 06:00 POSITION). THERE WAS A 1MM HOLE ALONG THE MELTED PART CLOSEST TO THE HANDPIECE. SURGEON WAS INFORMED. NO HARM TO PATIENT OR STAFF.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RIGHT FRONTAL CRANIOTOMY FOR RESECTION OF TUMOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #4IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351945 SONOPET DISPOSABLE TUBING SET AND EXTENDER FILTER TUBING INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS,DIV OF STRYKER CORP * 0198610
    351946 SONOPET SPETZLER BARRACUDA TIP UNIVERSAL INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS,DIV OF STRYKER CORP * 0186840
    351947 SONOPET ULTRASONIC SURGICAL SYSTEM INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS,DIV OF STRYKER CORP UST-2001 *
    352104 MOR SONOPET SYSTEM INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS,DIV OF STRYKER CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR