BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII OPTICAL ACCESS SYSTEM Z-THREADED SLEEVE 5MM X 100MM

    MDR report key: 4180338 · Received October 7, 2014

    Report

    Report Number
    4180338
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 7, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MULTIPLE ENDOSCOPIC INSTRUMENTS PASSED THROUGH THE TROCAR SLEEVE. IT WAS DISCOVERED THAT THE TIP OF THE SLEEVE WAS BROKEN. THE SURGEON MADE SEVERAL ATTEMPTS RETRIEVING FOREIGN OBJECTS FROM THE CAVITY. AFTER FURTHER EXPLORATION AND IRRIGATION, THE SURGEON FELT ALL PIECES WERE RETRIEVED SUCCESSFULLY WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627661 KII OPTICAL ACCESS SYSTEM Z-THREADED SLEEVE 5MM X 100MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL CTR03 2977119

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR ACTUALLY OCCURRED.| THIS DEVICE AND SURGEON UNAWARE OF WHEN THE DAMAGE| MULTIPLE ENDOSCOPIC INSTRUMENTS PASSED THROUGH| NO OTHER THERAPIES