BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL W/CONSOLE 110V AC WITH FOOTSWITCH

    MDR report key: 2971100 · Received February 1, 2013

    Report

    Report Number
    3006697299-2013-00010
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 1, 2013
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INFORMATION.

    Description of Event or Problem · 1

    THE SECOND REPORT OF TWO INVOLVING THE SAME PRODUCT FROM THE SAME FACILITY BUT WITH A DIFFERENT SERIAL NUMBER. INITIALLY CUSA CONSOLED AND 2 CUSA HANDPIECES WERE REPORTED AS HAVING "NO CAVITATION". THE HOSPITAL STAFF REPORTED THAT "THE AMPLITUDE WAS DROPPING BACK TO 10% AND NOT FUNCTIONING AS EXPECTED AND THAT IT WAS A "PARTICULARLY TOUGH TUMOUR". A CURVED EXTENDED TIP WAS USED FOR THE SURGERY. THE PATIENT WAS NOT INJURED, HOWEVER, IT CAUSED A DELAY OF AT LEAST 15 MINUTES. THE PATIENT DID HAVE A 'VERY HARD TUMOR' AND THEY DID HAVE TROUBLE REMOVING THE TUMOR WITH THE CUSA RESULTING IN VARIOUS TIPS BEING USED (ONE WAS THE (B)(4)). (UNABLE TO GET INFORMATION ABOUT WHICH OTHER CUSA TIPS WERE USED). THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. THE OUTCOME OF REMOVING THE TUMOR WITH THE OTHER PRODUCT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45251 CUSA EXCEL W/CONSOLE 110V AC WITH FOOTSWITCH ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR