BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6011621 · Received October 7, 2016

    Report

    Report Number
    9612501-2016-00722
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    August 5, 2016
    Report Date
    September 12, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    UDI-DI
    10884521100008
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: SINCE THE LOT NUMBER WAS NOT PROVIDED, THIS INFORMATION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE ENDO STITCH NEEDLE DROPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663445 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 10884521100008

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR