BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1343007 · Received March 11, 2009

    Report

    Report Number
    1219930-2009-00188
    Event Type
    Injury
    Date Received
    March 11, 2009
    Date of Event
    February 17, 2009
    Report Date
    March 3, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPROSCOPIC VAGINAL CUFF REPAIR. ACCORDING TO THE REPORTER: DURING USE, A SMALL FRAGMENT OF THE NEEDLE WAS LOST IN THE PT. THE FRAGMENT WAS FOUND AND AN ATTEMPT WAS MADE TO REMOVE THIS SMALL TIP OF THE NEEDLE WHICH WAS PROBABLY LESS THAN ONE TENTH OF A CENTIMETER LONG AND AN X-RAY WAS DONE INTRAOPERATIVELY, AND THERE WAS NO EVIDENCE OF NEEDLE TIP NOTED IN THE PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N8B127

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other