BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CIRCULAR STAPLERS

    MDR report key: 726025 · Received June 7, 2006

    Report

    Report Number
    1527736-2006-02601
    Event Type
    Malfunction
    Date Received
    June 7, 2006
    Date of Event
    May 16, 2006
    Report Date
    May 18, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GAG
    PMA / PMN Number
    k983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (510(K)#K983536)

    Description of Event or Problem · 1

    DURING A LOWER ANTERIOR RESECTION PROCEDURE, THE DOCTOR FIRED THE DEVICE AND COULD NOT REMOVE IT, BECAUSE IT WAS CATCHING ON THE ASASTOMOSIS SITE. EVENTUALLY, THE CIRCULAR STAPLER RELEASED, BUT IT RIPPED THE ANASTOMOSIS. UPON EXAMINATION OT THE TISSUE RINGS, NO PLASTIC WASHER COULD BE FOUND AND ONLY THE PROXIMAL TISSUE RING WAS VISABLE. THE DOCTOR REMOVED SOME OF THE STAPLES AND THEY WERE NOT COMPLETELY FORMED. THE DOCTOR HAD TO HAND SEW THE ANASTOMOSIS. THE EVENT CAUSE THE SURGERY TO LAST APPROXIMATELY ONE AND A HALF HOURS LONGER BECAUSE THE DOCTOR HAD TO HAND SEW THE ANASTOMOSIS. THE DOCTOR FELT HE CREATED A GOOD ANASTOMOSIS AND THE PATIENT SHOULD DO FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CIRCULAR STAPLERS GDW GAG ETHICON ENDO SURGERY, INC. NA A4C299

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN