BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 1810132 · Received August 17, 2010

    Report

    Report Number
    2647580-2010-00715
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 12, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDO
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CLIPS FAILED TO OCCLUDE THE VESSEL, RESULTING IN UNNECESSARY BLOOD LOSS AND MORE DISSECTION AROUND THE VESSEL TO GAIN CONTROL OF THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP S-9.0 TITANIUM DISPOSABLE CLIP APPLIER GDO USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| S