BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3222104 · Received July 1, 2013

    Report

    Report Number
    1219930-2013-00499
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE SUTURE IS TANGLING AND NOT ALLOWING THE DEVICE TO TOGGLE BACK AND FORTH. SURGEON HAD TO CUT THE SUTURE LOOSE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC. 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
    297543 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN, FORMERLY US SUR N3A0554X

    Patients

    Seq Age Sex Outcome Treatment
    1