BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3032075 · Received March 6, 2013

    Report

    Report Number
    1219930-2013-00134
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). .

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE DEVICE WAS DIFFICULT TO TOGGLE AND THE NEEDLE BROKE. THE NEEDLE BROKE INSIDE THE PT'S CAVITY AND WAS RETRIEVED FROM THE PT. THERE WAS NO UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THERE WAS NO TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THERE WAS NO BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM. NO OPERATIVE TIME WAS NOT EXTENDED OVER THIRTY MINUTES DUE TO THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96459 ENDO STITCH 10MM SUTURING DEVICE SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL N2L0428X

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUFACTURE DATE: 08/2012| 170053, ENDO STITCH POLYSORB 2/0 48 VIO DLU SU,| LOT NUMBER: B2H0002X, EXP DATE: 08/31/2017,