BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 2182360 · Received July 11, 2011

    Report

    Report Number
    8010219-2011-00009
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    INTEGRA, ANDOVER
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSA EXCEL 36 KHZ STRAIGHT HAND PIECE FAILED (IT DID NOT HAVE ANY ASPIRATION) DURING A CRANIOTOMY FOR TUMOR REMOVAL A FEW WEEKS AGO (SPECIFIC DATE UNKNOWN). THE UNIT WAS CHANGED TO ANOTHER HAND PIECE AND IT WORKED FINE. THERE WAS NO SURGICAL DELAY AND NO INJURY INVOLVED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1