BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 1053137 · Received May 19, 2008

    Report

    Report Number
    1527736-2008-03164
    Event Type
    Injury
    Date Received
    May 19, 2008
    Date of Event
    April 4, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A OPEN COLON RESECTION PROCEDURE THERE WAS RESISTANCE IN FIRING THE DEVICE. THE DEVICE WAS RELOADED AND THE DEVICE WAS DIFFICULT TO FIRE, BUT COMPLETED THE CASE. POST-OP THE STAPLE LINE WAS LEAKING AND MALFORMED WERE FOUND. SOME BLEEDING, BUT NO TRANSFUSION OCCURRED. SUTURING WAS USED TO COMPLETE THE CASE WITH NO FURTHER CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4JY8E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention