BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 1075611 · Received July 14, 2008

    Report

    Report Number
    1219930-2008-00514
    Event Type
    Injury
    Date Received
    July 14, 2008
    Date of Event
    April 3, 2008
    Report Date
    July 2, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY REPORTED ON 04/03/2008, HOWEVER, THE ONLY DETAILS AVAILABLE AT THAT TIME INDICATED THAT THE "INSTRUMENT WAS INOPERABLE". ADD'L INFO WAS RECEIVED ON 07/02/2008 WHICH INDICATED THAT THE NEEDLE WAS LEFT IN THE PELVIC CAVITY.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LEIMYONA OF UTERUS. ACCORDING TO THE REPORTER: THE INSTRUMENT WAS IN-OPERABLE. PARTIAL OF THE ENDO STITCH NEEDLE RETAINED IN PELVIC 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 N7L60

    Patients

    Seq Age Sex Outcome Treatment
    1 Other