BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1038543 · Received May 2, 2008

    Report

    Report Number
    1219930-2008-00348
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 7, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 05/02/2008. THREE LOTS WERE REPORTED TO HAVE MALFUNCTIONED DURING THIS PROCEDURE: N8A115 (MFR DATE: 01/2008; EXP. DATE: 01/31/2013), AND N8B05 (MFR DATE: 02/2008; EXP. DATE: 02/28/2013).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP NISSEN FUNDOPLICATION WITH GRAFT REINFORCEMENT REPAIR OF HIATAL HERNIA. ACCORDING TO THE REPORTER: THE SCRUB TECH LOADED DEVICE WITH NEEDLE, AND HANDED IT TO THE SURGEON, WHO THEN APPLIED IT TO TISSUE. THE SURGEON SAID "THE NEEDLE WAS BENDING AND POPPING OUT" OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N7G121

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR