BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3931752 · Received April 15, 2014

    Report

    Report Number
    1219930-2014-00302
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL MDR# 01 SENT TO FDA ON 09/30/2014.

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE NEEDLE IS STICKING IN THE JAWS, AND IT IS DIFFICULT TO PASS THROUGH TISSUE. THERE WAS NO PATIENT INJURY. THERE WAS NO TISSUE DAMAGE, UNANTICIPATED BLOOD LOSS, UNANTICIPATED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION, CONVERSION TO OPEN PROCEDURE, OR EXTENDED OPERATING ROOM TIME. ANOTHER ENDOSTITCH WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231002 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN, FORMERLY US SUR N3D0407X

    Patients

    Seq Age Sex Outcome Treatment
    1