BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO LINEAR CUTTERS-ETS45MM

    MDR report key: 559734 · Received May 11, 2004

    Report

    Report Number
    1527736-2004-01317
    Event Type
    Malfunction
    Date Received
    May 11, 2004
    Date of Event
    April 6, 2004
    Report Date
    April 13, 2004
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GASTRIC BYPASS WITH ROUX-EN-Y PROCEDURE, ONLY HALF OF THE CARTRIDGE DEPLOYED (LENGTH WISE). INSTRUMENT CUT WITH NO STAPLES ON ONE SIDE. SIX ADDITIONAL RELOADS WERE REQUIRED. THERE WAS NO REPORTED PATIENT CONSEQUENCE, ALTHOUGH O.R TIME WAS EXTENDED BY AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO LINEAR CUTTERS-ETS45MM ENDO LINEAR CUTTERS-ETS45MM KOG ETHICON ENDO SURGERY, INC.(CINCINNATI) NA U4YX95

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other