BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 2240839 · Received August 16, 2011

    Report

    Report Number
    8010219-2011-00012
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    INTEGRA, ANDOVER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 FIRST REPORT OF TWO INVOLVING AN EXCEL 36KHZ STRAIGHT HANDPIECE FROM THE SAME FACILITY. IT WAS REPORTED THAT DURING THE FIRST SURGERY, THE UNIT ONLY PERFORMED AT 70%. THE PT DID NOT INCUR AN INJURY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS GEI INTEGRA, ANDOVER

    Patients

    Seq Age Sex Outcome Treatment
    1