BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO STITCH SULU

    MDR report key: 6111889 · Received November 17, 2016

    Report

    Report Number
    9612501-2016-00923
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 20, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A FUNDOPLICATION WHILE STITCHING THROUGH THE STOMACH THE NEEDLE BROKE IN THE MIDDLE. THE NEEDLE PART COULD NOT BE FOUND ANYMORE. THE SURGEON DOES NOT SEE PROBLEM WHEN NEEDLE STAYS IN THE PATIENT. A NEW RELOAD WAS USED TO CORRECT THE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760370 UNKNOWN ENDO STITCH SULU ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other