BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 1040334 · Received May 8, 2008

    Report

    Report Number
    MW5006784
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Product Code
    FDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PENTAX GASTROSCOPE MODEL EG-29901 IS FITTED WITH BUTTONS TO CONTROL SUCTION AND AIR DELIVERY THROUGH THE SCOPE. THE SUCTION BUTTON IS MARKED WITH A RED DOT ON THE CENTER OF THE OUTER SURFACE TO INDICATE IT IS THE SUCTION BUTTON. THE PENTAX BRONCHOSCOPES ALSO HAVE A SUCTION BUTTON THAT IS IDENTICAL IN EXTERNAL APPEARANCE TO THE GASTROSCOPE SUCTION BUTTON AND WHICH CAN BE PLACED INTO A GASTROSCOPE MODEL EG-29901. WHEN A BRONCHOSCOPE BUTTON IS PLACED IN A GASTROSCOPE, IT APPEARS TO WORK CORRECTLY, HOWEVER, THE SUCTION CHANNEL IS ALWAYS ON, SUCTIONING GAS FROM THE STOMACH, AND PREVENTING INFLATION OF THE STOMACH. WITH A COLLAPSED STOMACH, IT IS NOT POSSIBLE TO PERFORM AN ADEQUATE DIAGNOSTIC EXAMINATION. IN THIS CASE, THE BRONCHOSCOPE BUTTON WAS PLACED IN THE GASTROSCOPE. THE ERROR WAS NOT APPARENT UNTIL AFTER THE SCOPE WAS FOUND NOT TO BE ABLE TO INSUFFLATE THE STOMACH. THE ENDOSCOPY WAS STOPPED AND HAD TO BE REPEATED DUE TO THE ERROR. TWO MONTHS AGO, IN THE SAME FACILITY, AN IDENTICAL ERROR OCCURRED. IN THAT CASE THE ENDOSCOPY WAS REPEATED TWICE BEFORE THE ERROR WAS DISCOVERED BEFORE THE THIRD INSERTION OF THE ENDOSCOPE. AT THAT TIME THE STAFF WAS NOTIFIED OF THE DEFECTIVE DESIGN OF THE SCOPE, AND PLANS WERE MADE TO KEEP BRONCHOSCOPE AND GASTROSCOPE PARTS SEPARATE. THIS SAFETY PLAN HAS NOW BEEN SHOWN TO BE INEFFECTIVE. THE PENTAX DEVICE IS OF DEFECTIVE DESIGN DUE TO PARTS WITH DIFFERENT FUNCTION BEING ABLE TO FIT A DEVICE, THEY ARE NOT INTENDED FOR AND CAUSING AN ENDOSCOPIC PROCEDURE TO BE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX GASTROSCOPE FDS EG-29901

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other