BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3032097 · Received March 6, 2013

    Report

    Report Number
    1219930-2013-00147
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    COVIDIEN, FORMERLY UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP PARAESOPHAGEAL HERNIA. ACCORDING TO THE REPORTER: THE STAPLER DID NOT STAPLE TISSUE WHEN FIRED. HANDLE WAS VERY STICKY AND STIFF TO USE. ANOTHER DEVICE WAS OPENED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96546 ENDO STITCH 10MM SUTURING DEVICE SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY UNITED STATES SURGICAL N1G0259

    Patients

    Seq Age Sex Outcome Treatment
    1