BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII OPTICAL ACCESS SYSTEM

    MDR report key: 2888722 · Received December 20, 2012

    Report

    Report Number
    MW5028337
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE PNEUMOPERITONEUM WAS LOST. CAMERA TROCAR WAS NOTED TO BE BROKEN WITH MULTIPLE CRACKS. TROCAR WAS REMOVED AND REPLACED WITH A NEW ONE. PNEUMOPERITONEUM REPLACED WITH NEW ONE. PNEUMOPERITONEUM WAS RESTORED TO NORMAL PRESSURES. DATES OF USE: (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: ROBOTIC PROSTATECTOMY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KII OPTICAL ACCESS SYSTEM ROBOTIC CAMERA TROCAR GCJ APPLIED MEDICAL C0R30 1153197

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention