BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1112754 · Received August 11, 2008

    Report

    Report Number
    1219930-2008-00599
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 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

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 08/11/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THERE WAS DIFFICULTY LOADING AND UNLOADING THE DEVICES AND THE NEEDLES WERE FALLING OUT. THE 3 DEVICES ONLY WORKED INTERMITTENTLY. ONE TIME THE NEEDLE FELL INTO THE CAVITY BUT WAS RETRIEVED. OR TIME WAS EXTENDED 10 MINUTES DUE TO THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N8E500

    Patients

    Seq Age Sex Outcome Treatment
    1