BEUDAMED
    FDA Adverse Event Summary report: N

    12X150MM KII OPTICAL ACCESS SYSTEM NON-THREADED

    MDR report key: 1981798 · Received January 26, 2011

    Report

    Report Number
    2027111-2011-00005
    Date Received
    January 26, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 26, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANTICIPATED TO RETURN. F/U REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY -"DR. (B)(6) WAS ABOUT HALFWAY THROUGH THE PROCEDURE WHEN THE REP WAS CALLED INTO THE ROOM TO BE SHOWN THAT THE CANNULA HAD CRACKED AT THE POINT OF ROBOTIC CLAMP ATTACHMENT. THE TROCAR WAS REPLACED WITH A NEW 12 X 150 SMOOTH AND THE ROBOT RE-CLAMPED TO THE NEW TROCAR. THE REST OF THE PROCEDURE WAS WITHOUT INCIDENT. THE CLAMP WAS ORIGINALLY PLACED DIRECTLY UNDERNEATH THE TAPER OF THE SEAL. THE HOSP WILL RELEASE THE PRODUCT ONCE THEY HAVE DONE AN ANALYSIS AND REPORT ON THE INCIDENT. NOT CLEAR WHETHER ANY CANNULA FELL INTO PT ABDOMEN." "CT SCAN AND X-RAY WERE TAKEN TO DETERMINE IF ANY PIECES OF CANNULA FELL INTO PT ABDOMEN WHEN CANNULA CRACKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X150MM KII OPTICAL ACCESS SYSTEM NON-THREADED NONE GCJ APPLIED MEDICAL C0R30 1127402

    Patients

    Seq Age Sex Outcome Treatment
    1