BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL 23KHZ STRAIGHT HANDPIECE

    MDR report key: 2061508 · Received March 16, 2011

    Report

    Report Number
    8010219-2011-00004
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    INTEGRA, ANDOVER
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A CUSA EXCEL 23 KHZ C2600 WAS INVOLVED IN AN EVENT AND WAS DESCRIBED AS FOLLOWS; A SHARP NOISE OCCURRED WHEN THE FOOT SWITCH WAS STEPPED ON. THE TIP WAS BROKEN AFTER THE SWITCH WAS STEPPED ON THREE TIMES. THE OUTPUT ONLY SHOWED 10%. THERE WAS PATIENT CONTACT, BUT NO INJURY AND NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL 23KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA, ANDOVER

    Patients

    Seq Age Sex Outcome Treatment
    1