BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA

    MDR report key: 1911079 · Received November 1, 2010

    Report

    Report Number
    1911079
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MEDIUM LIGACLIP WAS USED TO CLIP A VESSEL. HOWEVER, THE CLIP SHEARED THE VESSEL AND CAUSED A TEAR IN THE EXTERNAL JUGULAR VEIN. THE VEIN WAS REPARED WITHOUT INCIDENT, AND MINOR HARM WAS DONE TO THE PATIENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE LIGACLIP MALFUNCTIONED CAUSING SHEARING OF THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LIGACLIP MCA FZP ETHICON ENDO SURGERY * G4TJ5M

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR