BEUDAMED
    FDA Adverse Event Summary report: N

    12X150MM KII OPTICAL ACCESS SYSTEM THREADED

    MDR report key: 2046852 · Received February 23, 2011

    Report

    Report Number
    2027111-2011-00023
    Date Received
    February 23, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 23, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE RETURNED UNIT WAS VISUALLY INSPECTED. THE UNIT DISPLAYED A CRACK ALONG THE CANNULA WALL. ONE UNIT WAS RETURNED FOR EVALUATION. ENGINEERING CONFIRMED THE CANNULA WAS CRACKED ALONG THE CANNULA WALL. THE CRACKS WERE MOST LIKELY CAUSED BY THE DA VINCI MOUNT. THE C0R31 MODEL IS NOT QUALIFIED FOR USE WITH THE DA VINCI ROBOT SYSTEM. APPLIED RECOMMENDS REVIEW OF THE INTUITIVE SURGICAL, INC'S (DA VINCI ROBOT MANUFACTURER) INSTRUMENTS AND ACCESSORIES TO UNDERSTAND WHICH APPLIED MEDICAL TROCARS HAVE BEEN VALIDATED FOR USE WITH THE DA VINCI ROBOT AND THE CORRESPONDING ADAPTERS. INTUITIVE SURGICAL, INC SUPPLIES A VALIDATED MOUNT (MODEL # 371528) FOR APPLIED MEDICAL NON-THREADED TROCAR MODELS. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY - "C0R31 CRACKED WHILE IN THE CLAMP OF THE DA VINCI SI ROBOT. THERE WAS A LOSS OF PNEUMOPERITONEUM. TROCAR WAS REMOVED AND REPLACED." MEDWATCH REPORTED: "PATIENT HAD LOW TO NO PNEUMOPERITONEUM ABDOMINAL PRESSURE FOR APPROXIMATELY 50 MINUTES. DISCOVERED A 12 MM TROCAR HAD A CRACK. TROCAR WAS REPLACED AND PRESSURE RETURNED TO NORMAL. APPLIED MEDICAL REPRESENTATIVE NOTIFIED. TROCAR GIVEN TO REP FOR RETURN TO COMPANY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X150MM KII OPTICAL ACCESS SYSTEM THREADED NONE GCJ APPLIED MEDICAL C0R31 1128261

    Patients

    Seq Age Sex Outcome Treatment
    1