BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER CS

    MDR report key: 646428 · Received November 14, 2005

    Report

    Report Number
    1527736-2005-05452
    Event Type
    Injury
    Date Received
    November 14, 2005
    Date of Event
    October 24, 2005
    Report Date
    November 4, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAR PROCEDURE, THERE WAS ABOUT A 5MM HOLE AT THE BOWEL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. LEAKED TWO DAYS POST OP. RE-OPERATION WAS PERFORMED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER CS CONTOUR CURVED CUTTER STAPLER CS GDW ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention