BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR31 12X150MM, KII OPTICAL ACCESS SYSTEM

    MDR report key: 2082589 · Received April 28, 2011

    Report

    Report Number
    2082589
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 28, 2011
    Manufacturer
    INTUITIVE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    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 THE ENTIRE TIME, CREATING THE LOSS OF GAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COR31 12X150MM, KII OPTICAL ACCESS SYSTEM TROCAR PORT GCJ INTUITIVE COR31 12X150MM 1134872

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR