BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLER - ETS FLEX

    MDR report key: 418239 · Received September 24, 2002

    Report

    Report Number
    418239
    Event Type
    Malfunction
    Date Received
    September 24, 2002
    Date of Event
    August 6, 2002
    Report Date
    August 22, 2002
    Manufacturer
    ETHICON J & J
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLER WAS USED ON A PT HAVING LAPAROSCOPIC PROCEDURE FOR HYSTERECTOMY. PART OF THE STPALER CAME OFF THE APPLIER AND REMAINED IN THE ABDOMEN. OPEN PROCEDURE, DONE TO RETRIEVE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAPLER - ETS FLEX STAPLER KOG ETHICON J & J ETS FLEX P502 040 P39

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other