BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH SURGIDAC 0 48 GRN DLU SU

    MDR report key: 974323 · Received January 3, 2008

    Report

    Report Number
    1219930-2008-00003
    Event Type
    Injury
    Date Received
    January 3, 2008
    Date of Event
    September 21, 2007
    Report Date
    November 20, 2007
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAW
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REASSESSED BASED ON ADDITIONAL INFORMATION RECEIVED ON 01/02/2008 AND DETERMINED TO BE MDR REPORTABLE AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    PROCEDURE: UNK. ACCORDING TO THE REPORTER: WHEN DOING AN ENDO-SUTURING, THE NEEDLE BROKE OFF FROM SUTURE EXACTLY FROM CONJUNCTION PART OF NEEDLE AND SUTURE. THE SUTURE DISENGAGED INTO THE PATIENT CAVITY AND WAS RETRIEVED. SURGICAL TIME WAS EXTENDED 30 MINUTES TO RETRIEVE THE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SURGIDAC 0 48 GRN DLU SU NI GAW NORTH HAVEN - USS A6H72

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other