BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3961421 · Received May 29, 2014

    Report

    Report Number
    9612501-2014-00162
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: DURING THE CASE, THEY HAD TO OPEN 5 ENDOSTITCH DEVICES BECAUSE THE NEEDLES WEREN'T TOGGLING PROPERLY. NO ADVERSE OUTCOME FOR THE PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315805 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN J3L1626X

    Patients

    Seq Age Sex Outcome Treatment
    1