BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 4241365 · Received November 10, 2014

    Report

    Report Number
    9612501-2014-00402
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP REPORT SENT TO FDA ON 03/11/2015.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: HYSTERECTOMY.ACCORDING TO THE REPORTER: THE SURGEON WAS USING THE DEVICE AND WAS CLOSING THE VAGINAL CUFF. AT SOME POINT, THE NEEDLE BROKE OFF IN THE TISSUE. HALF THE NEEDLE WAS IN THE PATIENT AND HALF THE NEEDLE CAME OUT WITH THE DEVICE. THE SURGEON SPENT 15 MINUTES RETRIEVING THE BROKEN NEEDLE. PATIENT IS FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723736 ENDO STITCH* 10MM SUTURING DEVICE SINGLE USE SUTURING DEVICE KOG COVIDIEN 173016 J4B1125X

    Patients

    Seq Age Sex Outcome Treatment
    1