BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3963693 · Received May 2, 2014

    Report

    Report Number
    9612501-2014-00135
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE JAWS OF THE DEVICE WOULD NOT OPEN COMPLETELY. THE NEEDLE WOULD NOT TRANSFER TO THE OTHER SIDE. THERE WAS NO TISSUE DAMAGE, UNANTICIPATED BLOOD LOSS, UNANTICIPATED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION, CONVERSION TO OPEN PROCEDURE, OR EXTENDED OR TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265823 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN J3M0726X

    Patients

    Seq Age Sex Outcome Treatment
    1