BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 100MM SUTURING DEVICE

    MDR report key: 3063462 · Received March 28, 2013

    Report

    Report Number
    1219930-2013-00213
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP NISSEN. ACCORDING TO THE REPORTER: ONCE THE CARTRIDGE WAS ATTACHED TO THE HANDLE THE NEEDLE WOULD NOT TOGGLE. DOCTOR USED ANOTHER 173016 TO CONTINUE THE CASE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127446 ENDO STITCH 100MM SUTURING DEVICE SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1