BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ TUBING SET

    MDR report key: 3832333 · Received February 10, 2014

    Report

    Report Number
    3006697299-2014-00012
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 22, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    DURING A LIVER RESECTION, THE USER FOUND SALINE LEAKING BETWEEN THE BLUE TUBING AND CLEAR TUBING. ANOTHER TUBING SET WAS USED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2014, THE FOLLOWING WAS PROVIDED: THE NURSE REALIZED THAT THE SALINE SOLUTION WAS LEAKING FROM THE IRRIGATION TUBE (BETWEEN THE BLUE TUBING AND THE CLEAR TUBING NEAR THE SURGICAL FIELD). THE PRODUCT WAS IN USE "AFTER A LITTLE WHILE" BEFORE THE PROBLEM OCCURRED. NO INFORMATION WAS PROVIDED REGARDING PATIENT AGE AND GENDER. THERE WAS NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87956 CUSA EXCEL 36KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1