BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERPRT PLUS RPF 5MM-12MM TRC W/100MM SLV

    MDR report key: 1640865 · Received March 23, 2010

    Report

    Report Number
    2647580-2010-00353
    Event Type
    Death
    Date Received
    March 23, 2010
    Date of Event
    February 16, 2010
    Report Date
    February 22, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954108
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC ORCHIDOPEXY. ACCORDING TO THE REPORTER: THE VERSAPORT 10/12MM PORT WAS INSERTED USING THE HASSON TECHNIQUE. A LITTLE BLOOD WAS NOTED IN THE OBTURATOR/TROCAR ON WITHDRAWAL. SUBSEQUENTLY, IT WAS FOUND THAT THERE WAS A LACERATION IN THE IVC (INFERIOR VENA CAVA). THE LACERATION WAS OVERSEWN BY THE CARDIAC SURGEON, SO THE PATIENT DID NOT BLEED TO DEATH. REPORTEDLY, THE CAUSE OF THE EVENT WAS THE LACERATED IVC, HOWEVER, ACCORDING TO THE AUTOPSY, THE CAUSE OF DEATH WAS AN EMBOLISM TO THE HEART CAUSED BY AIR ENTERING THE LACERATED IVC. THE PATIENT EXPIRED ON THE TABLE THE SAME DAY OF THE PROCEDURE (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERPRT PLUS RPF 5MM-12MM TRC W/100MM SLV DISPOSABLE SURGICAL ACCESS DRIVE GCJ USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death