BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ CURVED EXTENDED STANDARD TIP

    MDR report key: 3901718 · Received May 5, 2014

    Report

    Report Number
    3006697299-2014-00031
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 9, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORTS REGARDING C4614S-CUSA EXCEL 36KHZ CURVED EXTENDED STANDARD TIP (SAME PRODUCT ID, SAME LOT NUMBER, SAME USER FACILITY, DIFFERENT PATIENTS). IT WAS REPORTED THAT THE TIP WAS ASSEMBLED TO THE HANDPIECE AND IT STOPPED WORKING AS THE EQUIPMENT WAS BEING USED. A TIP WITH SAME SKU BUT DIFFERENT LOT NUMBER WAS PUT ON THE HANDPIECE AND EQUIPMENT WORKED PROPERLY. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY. BOTH TIPS WERE FROM LOT 1132978. THE SALES REPRESENTATIVE ALSO - TRIED THE TWO TIPS ON A DIFFERENT HANDPIECE AND THEY STILL DIDN'T WORK. THE SALES REPRESENTATIVE THEN TRIED ANOTHER TIP ON THE HANDPIECE OF A DIFFERENT LOT AND IT WORKED. THE HANDPIECE IS OK. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER HAS BEEN REQUESTED. TO DATE, NO NEW INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268306 CUSA EXCEL 36KHZ CURVED EXTENDED STANDARD TIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1