BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 4240977 · Received November 10, 2014

    Report

    Report Number
    3005075853-2014-07788
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS THE PATIENT¿S CURRENT CONDITION? HOW WAS THE BLEED IDENTIFIED? WAS THE PATIENT SCOPED? WERE THERE ANY STAPLE FORM ISSUES? PATIENT WAS DOING WELL AT THE TIME I SUBMITTED THE COMPLAINT. NO REASON TO BELIEVE THAT CHANGED. PATIENT¿S BLOOD DYNAMICS CHANGED. VISUAL OBSERVATION OF BLOOD FROM THE RECTUM. PATIENT WAS SCOPED. STAPLE FORMATION ISSUES: UNKNOWN, EXCEPT THAT SURGEON DIDN¿T COMMENT ON ANY MALFORMED STAPLES.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC SIGMOID RESECTION PROCEDURE, AFTER A COLOPROCTOSTOMY USING AN ECS29 THE PATIENT BLED TRANSANALLY TWELVE HOURS POSTOP. THE PATIENT WAS GIVEN TWO UNITS OF BLOOD, NO ADDITIONAL SURGERY. THE DEVICE WAS DISPOSED AFTER THE FIRST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722013 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1