BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10 MM SUTURING DEVICE

    MDR report key: 3850795 · Received March 21, 2014

    Report

    Report Number
    1219930-2014-00221
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    October 25, 2013
    Report Date
    February 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHILE THE SCRUB TECH WAS REMOVING A SUTURE FROM THE ENDOSTITCH SUTURING DEVICE THE NEEDLE BROKE. PART OF THE NEEDLE REMAINED IN THE ENDOSTITCH. THIS HAPPENED AT THE STERILE FIELD AWAY FROM THE PT. THERE WERE NO INVOLVEMENT/CONTACT WITH THE PT. THERE WAS NO ANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500 CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT FELL INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170373 ENDO STITCH 10 MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL N3D0180X

    Patients

    Seq Age Sex Outcome Treatment
    1