BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 4093720 · Received September 12, 2014

    Report

    Report Number
    4093720
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE MALE PATIENT WAS UNDERGOING A LAPAROSCOPIC CHOLECYSTECTOMY WITH CHOLANGIOGRAM. DURING THE SURGICAL PROCEDURE, THE SURGEON WAS USING AN ETHICON 10MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER. THE 10MM CLIP MALFUNCTIONED BY NOT CLOSING. THEREFORE, TWO 5MM CLIP APPLIERS WERE USED. A SMALL AMOUNT OF BLEEDING OCCURRED WHICH EXTENDED THE SURGICAL TIME. THE PROCEDURE REMAINED LAPAROSCOPIC AND THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566268 LIGACLIP APPLIER, SURGICAL, CLIP GDO ETHICON ENDO-SURGERY, INC. * L4E90L

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NO.