BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH POLYSORB 0 48 U/D DLU SU

    MDR report key: 1213512 · Received October 27, 2008

    Report

    Report Number
    1219930-2008-00769
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 3, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP-ASSISTED TOTAL VAGINAL HYSTERECTOMY. ACCORDING TO THE REPORTER: WHILE CLOSING THE VAGINAL VAULT THE NEEDLE ON THE DEVICE BROKE OFF LEAVING A PORTION OF THE NEEDLE INSIDE THE PATIENT'S TISSUE. THE DEVICE WAS REMOVED, AND THE PATIENT WAS PLACED UNDER FLUORO. THE RETAINED NEEDLE PORTION WAS VISUALIZED. THE SURGEON EXCISED A PORTION OF TISSUE CONTAINING THE NEEDLE. ONCE REMOVED THE TISSUE WAS PLACED UNDER FLUORO, AND INDEED THE NEEDLE WAS CONTAINED IN THE EXCISED TISSUE. THE PATIENT WAS PLACED UNDER FLUORO AND CLEARLY THE NEEDLE PORTION WAS NO LONGER IN THE PATIENT. THE PROCEDURE WAS CLOSED IN THE USUAL MANNER AND THERE WERE NO ADVERSE EFFECTS FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH POLYSORB 0 48 U/D DLU SU DISPOSABLE SUTURE LOADING UNIT MFJ NORTH HAVEN - USS A8E310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention