BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1033052 · Received April 22, 2008

    Report

    Report Number
    1219930-2008-00315
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Report Date
    March 25, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE DEVICE WON'T HOLD NEEDLES. THE NEEDLE DISENGAGES DURING APPLICATION THROUGH TISSUE. THE NEEDLE WAS RETRIEVED WITHOUT DELAY IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N7L230

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK