BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    MDR report key: 1902135 · Received October 25, 2010

    Report

    Report Number
    1219930-2010-00811
    Event Type
    Injury
    Date Received
    October 25, 2010
    Report Date
    September 27, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDO
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS WAS RECEIVED AS A MAUDE EVENT REPORT REFERENCING REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: PT WAS ADMITTED TO THE HOSPITAL FOR ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE CLIPPING OF THE CYSTIC DUCT. THE CLIP MISFIRED TWO TO THREE TIMES CAUSING AN INCOMPLETE CLOSURE WHICH RESULTED IN MACERATED CYSTIC DUCT. THE SURGEON HAD TO USE A HARMONIC SCALPEL IN AN UNCONVENTIONAL FASHION AND SEARED THE DUCT CLOSED. AS THE SURGEON REMOVED THE STAPLER, IT GOT STUCK IN THE PORT AND BROKE AS IT CAME OUT. THE SURGEON DISCONTINUED USING THE CLIPS ON THE CYSTIC ARTERY AND USED THE HARMONIC SCALPEL INSERTED. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP DISPOSABLE CLIP APPLIER GDO UNITED STATES SURGICAL N0C0077

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability