BEUDAMED
    FDA Adverse Event Other Summary report: N

    12X100MM KII Z-THREAD ACC SYS W/SHLD BID OBTURATOR

    MDR report key: 1981196 · Received January 26, 2011

    Report

    Report Number
    2027111-2011-00003
    Event Type
    Other
    Date Received
    January 26, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 26, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO THE MANUFACTURER FOR REVIEW. AN ENGINEERING ASSESSMENT OF THE INCIDENT IS CURRENTLY BEING CONDUCTED AND A FOLLOW-UP REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    ROBOTIC MYOMECTOMY- "CASE BEGAN AS A DIAGNOSTIC LAPAROSCOPY TO DECIDE ON ROBOTIC OR PURELY LAPAROSCOPIC APPROACH. VERESS NEEDLE USED TO ESTABLISH PNEUMO, THEN A 5MM BLADED PLACED UMBILICUS. OTHER PORTS PLACED AFTER THAT. A 5MM PORT WAS REMOVED AND SOME PNEUMO WAS LOST. THE 5MM PORT WAS REPLACED WITH A 12MM BLADED PORT UNDER DIRECT VISUALIZATION. INJURY OCCURRED TO ILIAC." "VASCULAR SURGEON CALLED. PATIENT OPENED A COMMON ILIAC VEIN REPAIRED." DR INSERTED BLADED 12 THROUGH 5MM HOLE PERPENDICULAR TO PATIENT. PATIENT STATUS: STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII Z-THREAD ACC SYS W/SHLD BID OBTURATOR NONE GCJ APPLIED MEDICAL CTB73 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention