BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 3170651 · Received June 10, 2013

    Report

    Report Number
    8010047-2013-00179
    Event Type
    Death
    Date Received
    June 10, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    HIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT REPORTED EVENT. THE USER FACILITY DID NOT PROVIDE FURTHER INFORMATION REGARDING THE REPORTED EVENT AT THIS TIME AS THE SUBJECT UCR WAS QUARANTINED ALONG WITH THE OTHER FUJI EQUIPMENT AND ARE UNDERGOING AN INDEPENDENT ANALYSIS. HOWEVER, THE USER FACILITY DID NOT ALLEGE ANY MALFUNCTION WITH THE UCR. THE USER FACILITY STAFF FURTHER REPORTED THAT THEY WOULD BE PROVIDING US MORE INFORMATION AFTER THE INDEPENDENT ANALYSIS IS COMPLETED. TO DATE, THERE HAS BEEN NO FURTHER INFORMATION PROVIDED BY THE USER FACILITY. A REVIEW OF THE INSTRUMENT HISTORY SHOWED THAT THE DEVICE WAS PURCHASED ON (B)(6) 2012, BUT THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR SERVICE SINCE THEN. IN ADDITION, THE MANUFACTURING RECORD FOR THE SUBJECT DEVICE WAS CHECKED AND THERE WAS NO PROBLEM NOTED DURING THE MANUFACTURING OF THE DEVICE. THE EXACT CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED VIA MEDWATCH THAT: 'PATIENT DIED DURING AN ERCP. THE PROCEDURE WAS AN UPPER DEVICE ASSISTED ENTEROSCOPY WITHOUT FLUOROSCOPY. THE PATIENT WAS INTUBATED. THE SCOPE PASSED THROUGH THE MOUTH AND ADVANCED TO THE PROXIMAL ILEUM. AN AIR CHOLANGIOGRAM WAS OBTAINED. ABOUT 20 MINUTES IN TO THE PROCEDURE, THE PATIENT'S VITALS STARTED TO DROP, HEART RATE AND BLOOD PRESSURE. THE PATIENT'S CO2 THEN ALSO DROPPED. A CODE WAS CALLED AFTER THE PLUS BECAME INTERMITTENT AND THE SCOPE WAS WITHDRAWN.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 TRANSTHORACIC ECHOCARDIOGRAM (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
    261603 OLYMPUS ENDOSCOPIC CO2 REGULATION UNIT CO2 REGULATION UNIT HIF OLYMPUS MEDICAL SYSTEM CORPORATION UCR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death MODEL/SN# UNK| FUJINON SYSTEM 4400 LIGHT SOURCE ENDOSCOPE,