BEUDAMED
    FDA Adverse Event Summary report: N

    PENTAX

    MDR report key: 2621375 · Received June 11, 2012

    Report

    Report Number
    2518897-2012-00004
    Date Received
    June 11, 2012
    Date of Event
    May 8, 2012
    Report Date
    June 12, 2012
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    KOG
    PMA / PMN Number
    K934918
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EPK-I VIDEO PROCESSOR INVOLVED IN THIS EVENT WAS EVALUATED BY A PENTAX FIELD SERVICE TECHNICIAN AND IS PERFORMING WITHIN THE MANUFACTURERS SPECIFICATION. NO POST MORTEM WAS PERFORMED AND SO ROOT CAUSE COULD NOT BE SPECIFICALLY DETERMINED, POSSIBLE CAUSES FOR THE EVENT INCLUDE: PT CONDITION. OPERATOR SELECTION OF AIR PRESSURE LEVEL MAY HAVE CONTRIBUTED TO AN AIR EMBOLISM. A PERCUTANEOUS TRANSHEPATIC CATHETER WAS PRESENT AND MAY HAVE CONTRIBUTED TO AN AIR EMBOLISM DUE TO A PERSISTENT FISTULA WITHIN THE HEPATIC PARENCHYMA. PENTAX CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    PT PRESENTED WITH SEVERE CHRONIC PANCREATITIS AND JAUNDICE. THE PHYSICIAN PERFORMED AN ENDOSCOPIC ULTRASOUND PROCEDURE UNDER GENERAL ANESTHESIA WITH ERCP TO FOLLOW. WHILE THE PHYSICIAN WAS OBSERVING THE PAPILLA, THE PT WENT INTO CARDIAC ARREST AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO PROCESSOR KOG PENTAX MEDICAL COMPANY EPK-1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death ULTRASOUND VIDEO GASTROSCOPE:| VIDEO DUODENOSCOPE: PENTAX MODEL ED-3490TK,| SERIAL NUMBER (B)(4)| PENTAX MODEL EG-3490TK, SERIAL NUMBER (B)(4)| END TITAL CO2 MONITOR: DATEX.OHMEDA CARDIOCAP-5| PTC CATHETER: COOK MEDICAL 10 FRENCH CATHETER