BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 3024914 · Received March 15, 2013

    Report

    Report Number
    3006697299-2013-00017
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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

    A C2602, A 36 CUSA HAND PIECE 36 KHZ, WAS REPORTED TO HAVE OVERHEATED DURING AN UNSPECIFIED CASE. THE HAND PIECE DID NOT COME IN CONTACT WITH THE PT AND THE PT DID NOT INCUR AN INJURY AS A RESULT OF THIS INCIDENT. THE CASE WAS DELAYED FOR AN UNSPECIFIED AMOUNT OF TIME AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110408 CUSA EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LBK INTEGRA LIFESCIENCES IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1