BEUDAMED
    FDA Adverse Event Summary report: N

    KII 12 X 100 Z-THREADED OPT SEP SYSTEM

    MDR report key: 2255423 · Received September 9, 2011

    Report

    Report Number
    2027111-2011-00087
    Date Received
    September 9, 2011
    Date of Event
    August 3, 2011
    Report Date
    September 9, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVAL AND NO LOT# HAS BEEN PROVIDED TO THE MFR FOR REVIEW. ENGINEERING ASSESSMENT OF THE INCIDENT WILL BE CONDUCTED AND A F/U REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    ROBOTIC HYSTERECTOMY: "DR. (B)(6), INSUFFLATED WITH A VERESS NEEDLE AND WENT IN DIRECT WITH A NON-BLADED 12 MM Z-THREADED TROCAR. HE HAD DIFFICULTY GETTING IN WITH THIS TROCAR, SO HE ASKED FOR A BLADED 12 MM (C0R67) TROCAR. HE STARTED TO USE IT BUT WASN'T COMFORTABLE, SO HE SWITCHED BACK TO THE CTR73. HE CONTINUED WITH ENTRY AND UPON ENTERING THE ABDOMINAL CAVITY THE TROCAR PIERCED THE LEFT ILIAC ARTERY." PT STATUS: PT IS STILL IN THE HOSPITAL RECOVERING. TYPE OF INTERVENTION: UPON PIERCING THE ILIAC ARTERY THEY CONVERTED TO AN OPEN PROCEDURE AND CALL IN A GENERAL SURGEON TO REPAIR THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KII 12 X 100 Z-THREADED OPT SEP SYSTEM NONE GCJ APPLIED MEDICAL CTR73 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R TROCAR