BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS

    MDR report key: 3088635 · Received April 26, 2013

    Report

    Report Number
    MW5029985
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 26, 2013
    Manufacturer
    OLYMPUS AMERICA
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DIED DURING ERCP. THE PROCEDURE WAS AN UPPER DEVICE-ASSISTED ENTEROSCOPY WITHOUT FLUOROSCOPY. THE PT WAS INTUBATED. THE SCOPE WAS PASSED THROUGH THE MOUTH AND ADVANCED TO THE PROXIMAL ILEUM. AN AIR CHOLANGIOGRAM WAS OBTAINED. ABOUT 20 MINUTES INTO THE PROCEDURE, THE PT'S VITALS STARTED TO DROP HEART RATE AND BLOOD PRESSURE. THE PT'S CO2 THEN ALSO DROPPED. A CODE WAS CALLED AFTER THE PULSE BECAME INTERMITTENT AND THE SCOPE WAS WITHDRAWN. THERE WAS NO OBVIOUS EVIDENCE OF PERFORATION OR HEMORRHAGE DURING THE PROCEDURE. AN AIR EMBOLISM WAS DETECTED THROUGH A TEE. ONE HOUR OF CPR WAS PERFORMED WITHOUT ADEQUATE PERFUSION AND THE RESUSCITATION WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181894 OLYMPUS ENDOSCOPIE CO2 REGULATOR UNIT HET OLYMPUS AMERICA OLYMPUS UCR NA
    181895 FUJINON SYSTEM 4400 LIGHT SOURCE IYO FUJINON CORPORATION FUJIFILM MEDICAL SYSTEMS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death