BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 4242401 · Received November 11, 2014

    Report

    Report Number
    9612501-2014-00404
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE STITCH DISLODGED FROM JAWS TWICE. THE DEVICE WAS PASSED BACK INTO THE ABDOMEN WITH THE RELOADED NEEDLE, A PASS WAS ATTEMPTED ONE TIME AND THE NEEDLE DISLODGED AGAIN. THE DEVICE WAS REMOVED FROM THE CAVITY AND THE NEEDLE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727778 ENDO STITCH* 10MM SUTURING DEVICE SINGLE USE SUTURING DEVICE KOG COVIDIEN 173016 J4G1982X

    Patients

    Seq Age Sex Outcome Treatment
    1