BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP II MED/LRG 10MM PISTOL GRIP

    MDR report key: 1910222 · Received November 22, 2010

    Report

    Report Number
    1219930-2010-00885
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 25, 2010
    Manufacturer
    UNITED STATES SURGICAL A
    Product Code
    FZP
    PMA / PMN Number
    K954435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE CLIPS DO NOT CLOSE PROPERLY AND SOME OF THE CLIPS CAME OUT TWISTED. THE SURGEON HAD TO TRANSECT THE CYSTIC DUCT AND ALSO HAD TO PLACE ADD'L CLIPPING IN ORDER TO CORRECT THE ISSUE. THERE WAS A SMALL BILE LEAK THAT WAS CONTROLLED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS DELAYED MORE THAN THIRY MINUTES DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP II MED/LRG 10MM PISTOL GRIP DISPOSABLE CLIP APPLIER FZP UNITED STATES SURGICAL A N0F0663

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S