BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC CUTTER AND STAPLE CART.

    MDR report key: 4231840 · Received October 31, 2014

    Report

    Report Number
    MW5038968
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 31, 2014
    Manufacturer
    ETHICON ENDO-SURGICAL
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLER OF AN ETHICON ENDO-SURGERY TS-FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER WITH ENDOPATH ETS45 2.5MM VASCULAR CARTRIDGE WOULD NOT DEPLOY DURING A SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698504 ENDOSCOPIC CUTTER AND STAPLE CART. ENDOSCOPIC CUTTER AND STAPLE CART. KOG ETHICON ENDO-SURGICAL ATS45 L4F605
    698619 ENDOPATH ETS-FLEX25 ENDOPATH ETS-FLEX25 KOG ETHICON ENDO-SURGICAL ETS45 L4EY50

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR