BEUDAMED
    FDA Adverse Event Summary report: N

    12X150MM KII NON-THREADED OPTICAL ACCESS SYSTEM

    MDR report key: 1971794 · Received January 5, 2011

    Report

    Report Number
    2027111-2011-00002
    Date Received
    January 5, 2011
    Date of Event
    August 24, 2010
    Report Date
    January 5, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT# 1118832. INCIDENT DEVICE HAS BEEN RETURNED AND IS STILL UNDERGOING ENGINEERING EVALUATION. ADDITIONALLY, ANOTHER LOT NUMBER (#1117419) WAS PROVIDED TO US THAT WAS NOT REFLECTED ON MEDWATCH REPORT (B)(4), WE ARE RESEARCHING THE MANUFACTURING DETAILS FOR LOT #1117419 AS WELL AS #1118832. A FOLLOW-UP REPORT WILL PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: ROBOT - "WHEN DOCTOR WENT TO UNDOCK THE ROBOT, HE REMOVED THE TROCAR FROM THE CLAMP AND IT WAS CRACKED AND A PIECE WAS BROKEN OFF AND FELL INTO THE PATIENT." MEDWATCH REPORTED (B)(4): "VOLUM (B)(4) 2010: USING APPLIED MEDICAL TROCAR DURING TRIAL WITH ROBOTIC LAPAROSCOPIC PROSTATECTOMY. AT THE END OF CASE WHEN UNDOCKING ROBOT - NOTICED "CRACK" AND SEPARATION OF PORTION OF TROCAR SHEATH, DEFECT NOTED WHILE TROCAR STILL INSIDE PT. TROCAR CAREFULLY REMOVED AND SMALL PORTION OF TROCAR REMOVED FROM TROCAR SITE WITH HEMOSTAT. UPON "REASSEMBLING" TROCAR WITH ALL PIECES, IT APPEARS ALL DEBRIS WAS RECOVERED, PER SURGEON'S INSPECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X150MM KII NON-THREADED OPTICAL ACCESS SYSTEM NONE GCJ APPLIED MEDICAL C0R30 1117419

    Patients

    Seq Age Sex Outcome Treatment
    1