BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1082017 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00550
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 27, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 07/23/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: REFLUX ESOPHAGITIS / NISSEN. PEDIATRIC SURGERY. ACCORDING TO THE REPORTER: DURING USE, THE NEEDLE BROKE. THE BROKEN TIP WAS FOUND OUTSIDE OF THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO TISSUE DAMAGE. NO BLEEDING. NOTHING FELL INTO THE CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N7E446

    Patients

    Seq Age Sex Outcome Treatment
    1