BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 537992 · Received August 6, 2004

    Report

    Report Number
    1219930-2004-00187
    Event Type
    Injury
    Date Received
    August 6, 2004
    Date of Event
    July 12, 2004
    Report Date
    July 13, 2004
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, PART OF A NEEDLE BROKE OFF INTO THE PT CAVITY. MISSING PORTION OF NEEDLE NOT RETRIEVED FROM PT CAVITY. PROCEDURE: LGB. PT STATUS: NO PT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE GCJ NORTH HAVEN - USS NA N4E420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN