BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 4041019 · Received August 6, 2014

    Report

    Report Number
    1219930-2014-00619
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: NISSEN. ACCORDING TO THE REPORTER: "HANDLE BROKE". APPLIED ANOTHER DEVICE. THERE WAS NO TISSUE DAMAGE, UNANTICIPATED BLOOD LOSS, UNANTICIPATED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION, CONVERSATION TO OPEN PROCEDURE, OR EXTENDED OPERATING ROOM TIME. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459200 ENDO STITCH 10MM SUTURING DEVICE ENDO STITCH KOG COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1