BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 3122816 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02477
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOWER ANTERIOR BOWEL RESECTION PROCEDURE THE SURGEON FIRED THE FIRST FIRING THE DEVICE WOULD NOT FIRE, A SECOND DEVICE WAS USED AND IT WOULD NOT FIRE. THE SURGEON ALSO USED A CIRCULAR DEVICE AND THE DEVICE FIRED FINE, AND THE DONUTS WERE COMPLETE. A LEAK TEST WAS PERFORMED AND THE ANASTOMOSIS LEAKED. THE PATIENT WAS A CANCER PATIENT. IT IS UNKNOWN WHAT CAUSED THE LEAK. THE PROCEDURE WAS PERFORMED SO LOW IN THE ABDOMEN THAT THERE WAS NOT ENOUGH BOWEL TO CREATE ANOTHER ANASTOMOSIS. A COLOSTOMY WAS PERFORMED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224402 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention