BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STANDARD TIP

    MDR report key: 3368135 · Received September 10, 2013

    Report

    Report Number
    3006697299-2013-00067
    Event Type
    Malfunction
    Date Received
    September 10, 2013
    Date of Event
    August 16, 2013
    Report Date
    September 10, 2013
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 FIRST REPORT OF TWO FROM THE SAME FACILITY INVOLVING A CUSA 23KHZ TIP. THE FOLLOWING INFORMATION WAS PROVIDED. THE STAFF CHANGED THE NEW C4601S TIP (LOT NO. 1122361, EXP 2015-05). THEY SWITCHED OFF THE CUSA EXCEL MAIN SWITCH. THEY OPENED THE CUSA EXCEL MAIN SWITCH. THEY PUSHED THE "TEST" BUTTON. IT WAS REPORTED THAT TIP #1 BROKE INTO TWO PARTS AFTER 1 MINUTE DURING SETUP FOR LIVER SURGERY. THE UNIT WAS NOT IN CONTACT WITH A PATIENT WHEN IT BROKE. THE HAND PIECE SETTINGS WERE 70, 70, 70 AND A NOSECONE WAS BEING USED. IT WAS REPORTED THAT THE TIP DID NOT CONTACT ANOTHER INSTRUMENT OR TOOL. THE PATIENT DID NOT INCUR AN INJURY AND THE SURGERY WAS NOT DELAYED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453992 CUSA EXCEL 23KHZ STANDARD TIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED 1122361

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR