BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STANDARD TIP

    MDR report key: 3881096 · Received April 7, 2014

    Report

    Report Number
    3006697299-2014-00019
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    IT WAS INITIALLY REPORTED TWO CUSA EXCEL TIPS (PRODUCT ID: C4601, LOT NUMBERS 113630 AND 1133588) WERE USED ON A LIVER TUMOR PROCEDURE AND BOTH TIP ENDS BROKE OFF DURING USE. THE TIP END WAS LOST IN THE SURGICAL SITE FOR A SHORT TIME UNTIL THE SURGEON EVENTUALLY LOCATED IT. THE TIPS WERE NOT IN CONTACT WITH ANY OTHER INSTRUMENT, HOWEVER, THE CEM NOSECONE WAS BEING USED. THERE WAS NO PT INJURY REPORTED AND THE PRODUCT PROBLEM LED TO A 30 MIN INCREASE IN SURGERY TIME. ADD'L INFO WAS THEN RECEIVED ON (B)(6) 2014 WITH THE FOLLOWING: IT WAS CLARIFIED THAT ONLY ONE OF THE TWO CUSA EXCEL TIPS USED HAD ACTUALLY BROKEN OFF. THE USER HAD OPENED ANOTHER TIP TO REPLACE THE BROKEN TIP. THE REPLACEMENT TIP WORKED PERFECTLY WELL. THE USER COULD NOT REMEMBER WHICH PACKAGING AND LOT NUMBER WENT WITH WHICH TIP, HENCE TWO LOT NUMBERS WERE PROVIDED TO THE SALE REP WHEN IT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208390 CUSA EXCEL 23KHZ STANDARD TIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED 1131630 OR 1133588

    Patients

    Seq Age Sex Outcome Treatment
    1