BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 185332 · Received September 2, 1998

    Report

    Report Number
    185332
    Event Type
    Injury
    Date Received
    September 2, 1998
    Date of Event
    November 19, 1997
    Report Date
    August 3, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESISTANCE ENCOUNTERED ON ATTEMPT TO REMOVE STAPLING DEVICE. AFTER SOME DIFFICULTY, IT WAS REMOVED AND NOTED THAT IT HAD ONLY PARTIALLY FIRED AND NONE OF THE STAPLES WERE COMPLETELY FORMED. CUTTER HAD ONLY PARTIALLY CUT THROUGH RESECTION MARGINS. UNFORMED SUTURES WERE REMOVED FROM WOUND AND TISSUE. INCOMPLETE CUT DOUGHNUTS OF RESECTIONS MARGIN WERE EXCISED. HANDSEWN ANASTOMOSIS WAS THEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. 1 PROXIMATE ILS CURVED INTRALUMINAL STAPLER GAG ETHICON ENDO-SURGERY, INC. CDH33 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R