BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 1851152 · Received September 29, 2010

    Report

    Report Number
    1219930-2010-00764
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 27, 2010
    Report Date
    September 6, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    FZP
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: THE CLIPS WERE MALFORMED. THE SURGEON HAD TO CLIP THE VESSEL AGAIN TO CORRECT THE ISSUE. THIS RESULTED IN DAMAGE TO THE PATIENT TISSUE/VESSEL. THE MALFORMED CLIPS WERE REMOVED FROM THE PATIENT. THERE WAS NO ADDITIONAL BLOOD LOSS. THERE WAS NO ADDITIONAL OPERATING ROOM TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER FZP UNITED STATES SURGICAL N0B0147

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability