BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP* II MED/LRF 10MM PISTOL GRIP

    MDR report key: 3901531 · Received June 23, 2014

    Report

    Report Number
    9612501-2014-00192
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    PMA / PMN Number
    K954435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TOT HE REPORTER: THE CUSTOMER REPORTS THAT THE CLIP WAS PUT ON A BRANCH OF THE PULMONARY ARTERY, AND THE CLIPS COULD NOT HOLD TIGHT, 2 TIMES. THE ARTERY WALL HAD TO BE SECTIONED WHICH LEAD TO A THORACOTOMY. THERE WAS BLOOD LOSS OF MORE THAN 500 CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366107 ENDO CLIP* II MED/LRF 10MM PISTOL GRIP DISPOSABLE CLIP APPLIER FZP COVIDIEN J3L1427X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention