BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL

    MDR report key: 663147 · Received December 29, 2005

    Report

    Report Number
    663147
    Event Type
    Malfunction
    Date Received
    December 29, 2005
    Date of Event
    December 16, 2005
    Report Date
    December 29, 2005
    Manufacturer
    SURGX, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A LAPAROSCOPIC HYSTERECTOMY. THE TROCARS HAD ALREADY BEEN INSERTED AND THE SURGEON INTRODUCED THE DISPOSABLE LAPAROSCOPIC DEVICE. IT WAS NOTED ON THE SCREEN THAT THE TIP ENDS WERE MISSING. THE TEAM WAS UNCERTAIN WHETHER THE TIP DISENGAGED AND WAS INSIDE THE PATIENT OR WHETHER THE TIPS WERE MISSING WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. AN ABDOMINAL KUB (X-RAY OF THE KIDNEYS, URETERS AND BLADDER) WAS PERFORMED WHICH WAS NEGATIVE FOR A FOREIGN BODY. THE GARBAGE BIN WAS THOROUGHLY SEARCHED, AND THE FLOOR WAS SWEPT WITH A METAL DETECTING ROLLER. THE TIPS COULD NOT BE FOUND. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL 5 MM DISPOSABLE LAPAROSCOPIC DEVICE GCJ SURGX, INC. * WO5E17-01D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR