BEUDAMED
    FDA Adverse Event Summary report: N

    12X150MM KII OPTICAL ACCESS SYSTEM THREADED

    MDR report key: 2222705 · Received July 8, 2011

    Report

    Report Number
    2027111-2011-00068
    Date Received
    July 8, 2011
    Date of Event
    April 25, 2011
    Report Date
    July 8, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS NOT REPORTED TO APPLIED MEDICAL. WE HAVE CONTACTED THE HOSPITAL AND HAVE REQUESTED THE RETURN OF THE EVENT SAMPLE FOR OUR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: ROBOTIC ASSISTED HYSTERECTOMY - "DURING A ROBOTIC SURGERY, THE PHYSICIAN MOVED THE CAMERA AROUND INSIDE THE ABDOMEN AND NOTED TISSUE UP AGAINST IT, OBSTRUCTING THE VIEW. SO, THE SCRUB TECH WENT TO MOVE THE PORT AND ADVANCE IT WHEN THEY HEARD A NOISE AND NOTED THE PORT HAD CRACKED AND A PIECE OR TWO FLEW AWAY FROM THE PATIENT. THEY HAD BEEN LOSING GAS; HAVING PROBLEMS MAINTAINING PNEUMOPERITONEUM DURING THE WHOLE CASE AND BELIEVE THAT THERE WAS A CRACK IN THE PORT ENTIRE TIME, CREATING THE LOSS OF GAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X150MM KII OPTICAL ACCESS SYSTEM THREADED NONE GCJ APPLIED MEDICAL C0R31 1134872

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ROBOTIC