BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLE

    MDR report key: 1780758 · Received July 27, 2010

    Report

    Report Number
    2647580-2010-00653
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 18, 2010
    Report Date
    July 20, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    PROCEDURE: HEMORRHOIDECTOMY. ACCORDING TO THE REPORTER: THE STAPLE LINE DID NOT FIRE COMPLETELY AND SOME OF THE STAPLES DID NOT FORM PROPERLY. THE DEVICE WAS FIRED ON A VERY LARGE VASCULAR HEMORRHOID. THE STAPLE LINE WAS CORRECTED BY OVER SEWING WITH SUTURES. OPERATIVE TIME WAS EXTENDED BY ROUGHLY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLE DISPOSABLE STAPLE GDW USSC PUERTO RICO POA0448

    Patients

    Seq Age Sex Outcome Treatment
    1 Other