BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTAX

    MDR report key: 2671340 · Received July 20, 2012

    Report

    Report Number
    2518897-2012-00008
    Event Type
    Death
    Date Received
    July 20, 2012
    Date of Event
    June 23, 2012
    Report Date
    July 19, 2012
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    KOG
    PMA / PMN Number
    K934918
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EPK-I VIDEO PROCESSOR INVOLVED IN THIS EVENT WAS EVALUATED BY A PENTAX SALE REPRESENTATIVE AND (B)(6) HOSPITAL CLINICAL ENGINEER AND THE PROCESSOR IS PERFORMING WITHIN THE MANUFACTURER'S SPECIFICATIONS. HOSPITAL INFORMED PENTAX THAT THE PT HAD A PRE-EXISTING RESPIRATORY CONDITION, HOWEVER, NO FURTHER INFORMATION WAS RECEIVED FROM THE HOSPITAL SUCH AS IF POST MORTEM WAS PERFORMED AND SO CAUSE OF THE EVENT 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. PENTAX CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PHYSICIAN FROM (B)(6) HOSPITAL PERFORMED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON A (B)(6) FEMALE PT WHO DIED DUE TO A VENOUS AIR EMBOLISM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death SERIAL NUMBER: (B)(4)| VIDEO DUODENOSCOPE = PENTAX: MODEL: ED-3270K,