BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 3181626 · Received June 14, 2013

    Report

    Report Number
    3006697299-2013-00050
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PT, SAME PROCEDURE, SAME PRODUCT, DIFFERENT LOT NUMBER). IT WAS REPORTED THAT WHEN USING THE CUSA EXCEL 23KHZ HANDPIECE WITH THE LAPAROSCOPIC TIP AND CEM NOSECONE, THE DIATHERMY WAS AUTOMATICALLY ACTIVATED WITHOUT THE SURGEON PUSHING THE BUTTON. THE SAME INCIDENT HAPPENED WITH THE SECOND NOSECONE. THE CUSTOMER HAD TO EXCHANGE THE CEM NOSE CONE 3 TIMES. THE THIRD NOSE CONE WORKED AS EXPECTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271778 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED 0000001120773

    Patients

    Seq Age Sex Outcome Treatment
    1