BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 4040999 · Received August 6, 2014

    Report

    Report Number
    1219930-2014-00618
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 18, 2012
    Report Date
    June 21, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE:PNEUMONECTOMY. ACCORDING TO THE REPORTER: CUSTOMER REPORTS THAT THE BLACK BUTTON TO THE LOAD THE INSTRUMENT BROKE AND MADE THE INSTRUMENT UNUSABLE. THEY OPENED A SECOND DEVICE WITH A DIFFERENT LOT # BUT THE SAME PROBLEM OCCURRED. THEY USED A THIRD INSTRUMENT AND IT FINALLY WORKED FINE. NO PT INJURY OR ILL-EFFECTS. PT CURRENT STATUS REPORTED AS RECOVERED. THE DEVICE IS BEING RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460165 ENDO STITCH 10MM SUTURING DEVICE ENDO STITCH KOG COVIDIEN LP, FORMERLY US SURGICAL N2B0020X

    Patients

    Seq Age Sex Outcome Treatment
    1