BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 3143302 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02760
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 9, 2013
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLOSTOMY REVERSAL PROCEDURE, THE DEVICE FIRED AS INTENDED. THE STAPLE LINE LOOKED OK. THE DONUTS WERE COMPLETE. THE PURSE STRING WAS HAND SEWED. THE OTHER STAPLER USED IN THE PROCEDURE WAS A CONTOUR. THERE WAS BLEEDING ON THE ANASTOMOSIS LINE. THE PATIENT REQUIRED A BLOOD TRANSFUSION. THESE ARE ALL THE DETAILS PRESENTLY KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245027 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention