BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 2404300 · Received January 4, 2012

    Report

    Report Number
    2027111-2012-00001
    Date Received
    January 4, 2012
    Date of Event
    December 17, 2011
    Report Date
    January 4, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    LZN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS ARE BEING RETURNED FOR EVALUATION BUT LOT #S ARE PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT WITHIN 30 DAYS ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPAROSCOPIC TOTAL HYSTERECTOMY - "MR (B)(6) USED VERRES TO INSUFFLATE ABDOMEN. THE (B)(6) SISTER SAID CTB73 12 MM TROCAR WAS INSERTED INTO THE UMBILICUS AND STARTED LEAKING GAS AS SOON AS THE OBTURATOR WAS REMOVED FROM THE CANNULA. A 10MM SCOPE WAS INSERTED, BUT THE SEAL CONTINUED TO LEAK GAS, SO CHANGED THE CANNULA AND SEAL. A 1 X CTB12-2 X 5MM TROCARS WERE INSERTED LEFT AND RIGHT LATERALLY PLUS 1 X CTS02 INTO LOWER MIDLINE. BOTH LEFT AND RIGHT LATERAL CANNULAS LEAKED GAS INTERMITTENTLY WITH INSTRUMENT EXCHANGE. THE CASE WAS THEN CONVERTED FROM LAP TO OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR NONE LZN APPLIED MEDICAL CTB73 1156893

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STORTZ REUSABLE YEOHANS AND ALLIGATOR GRASPERS| MODEL # CTB12 - KII 5X100MM SHLD DUAL Z - THR| PLUS A HARMONIC ACE,