BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER

    MDR report key: 1881208 · Received October 20, 2010

    Report

    Report Number
    1219930-2010-00801
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    June 24, 2010
    Report Date
    September 21, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDO
    PMA / PMN Number
    K954435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING SURGERY, THE CLIPS WERE PLACED CORRECTLY ON THE TISSUE. THE NEXT DAY THE PT BECAME SEPTIC AND DURING RE-LAPAROSCOPY, IT APPEARED THAT THE CLIPS MOVED FROM THE CYSTIC DUCT AND HAD CAUSED A LOT OF BILE LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER DISPOSABLE CLIP APPLIER GDO UNITED STATES SURGICAL NOA0753

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R