BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3810394 · Received April 11, 2014

    Report

    Report Number
    9612501-2014-00108
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 15, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAVH. ACCORDING TO THE REPORTER: UPON LOADING THE SECOND SUTURE INTO THE ENDOSTITCH, THE DEVICE WOULD NOT TOGGLE. THERE WAS NO PT INJURY. THERE WAS NO BLEEDING OF 500 CC OR MORE. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THE PROCEDURE WAS NOT CONVERTED TO AN OPEN PROCEDURE. NOTHING FELL INTO THE PT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221701 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN J3M0304X

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR