BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1381171 · Received March 18, 2009

    Report

    Report Number
    1219930-2009-00205
    Event Type
    Malfunction
    Date Received
    March 18, 2009
    Date of Event
    February 25, 2009
    Report Date
    March 5, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO REPORTER: DURING THE CLOSURE OF THE VAGINAL VAULT, SUTURE AND NEEDLE WERE DISLODGED FROM THE INSTRUMENT AND FELL INTO THE PT CAVITY. IT TOOK 10 MINUTES TO LOCATE AND REMOVE ALL PIECES. WHEN IT RETRIEVED, IT WAS NOTED THAT THE NEEDLE HAD BEEN BROKEN. THERE WAS NO HARM TO PT. REPORTEDLY, THE PT'S TISSUE WAS NORMAL AND NOT OVERLY THICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N8K379

    Patients

    Seq Age Sex Outcome Treatment
    1