BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3793434 · Received April 4, 2014

    Report

    Report Number
    1060680-2014-00007
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    GENICON
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE REPORTED SAMPLE WAS RETURNED FOR EVALUATION. THE SUPPLIER WAS MADE AWARE OF THE ISSUE AND THE SAMPLE FORWARDED ON TO THEM FOR FURTHER INVESTIGATION. INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.

    Description of Event or Problem · 1

    THE DOCTOR WAS USING THE SPECIMEN RETRIEVAL BAG FOR A ROUTINE LAP CHOLE. THE BAG WAS DEPLOYED, GALLBLADDER PLACED IN THE BAG, AND ONCE THE THUMB RING AND INTRODUCER SHAFT WERE REMOVED, THE DOCTOR STARTED TO PULL THE WHITE DRAWSTRING BACK AND FORTH. THE BAG AND GALLBLADDER WERE HALF WAY OUT OF THE INCISION SITE WHEN THE SEAM AND WHITE STITCHING AT THE BOTTOM OF THE BAG GAVE OUT AND THE GAB CAME OPEN. THE GALLBLADDER WAS STUCK HALF HANGING OUT OF THE INCISION SITE AND THE DOCTOR WAS ABLE TO REMOVE IT FROM THAT POINT WITH THIS HAND. THE GALLBLADDER DID NOT BURST BUT IT WAS FULL OF HUNDREDS OF TINY GALLSTONES THAT COULD HAVE CAUSED A BIG PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205235 DEROYAL CONTAINER, SPECIMEN, STERILE GZJ GENICON

    Patients

    Seq Age Sex Outcome Treatment
    1