BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS DUODENOVIDEOSCOPE

    MDR report key: 4083606 · Received August 22, 2014

    Report

    Report Number
    2951238-2014-00355
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    January 1, 2013
    Report Date
    July 25, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDT
    PMA / PMN Number
    K024033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS OFFERED AN ON-SITE VISIT TO THE USER FACILITY TO ASSESS THEIR REPROCESSING PRACTICES, BUT THE USER FACILITY DECLINED. THE EXACT CAUSE OF THE PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. CROSS REFERENCE MFR. REPORT NUMBERS: 2951238-2014-00348, 2951238-2014-00349, 2951238-2014-00350, , 2951238-2014-00350, 2951238-2014-00351, 2951238-2014-00352, 2951238-2014-00353, 2951238-2014-00354, 2951238-2014-00356, 2951238-2014-00357 2951238-2014-00358, 2951238-2014-00359, 2951238-2014-00360, 2951238-2014-00361, 2951238-2014-00362, 2951238-2014-00363, 2951238-2014-00364, 2951238-2014-00365, 2951238-2014-00366, 2951238-2014-00367, 2951238-2014-00368, 2951238-2014-00369, 2951238-2014-00370, 2951238-2014-00371, 2951238-2014-00372, 2951238-2014-00373, 2951238-2014-00374, 2951238-2014-00375, 2951238-2014-00376, 2951238-2014-00377, 2951238-2014-00378, 2951238-2014-00379, 2951238-2014-00380, 2951238-2014-00381, 2951238-2014-00382, AND 2951238-2014-00383.

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY MULTIPLE TIMES VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENTS, BUT WAS UNSUCCESSFUL. THE INITIAL FOLLOW-UP WAS MADE ON JULY 28, 2014, VIA TELEPHONE AND IN WRITING. SUBSEQUENT FOLLOW-UPS WERE MADE ON THE FOLLOWING DATES: JULY 29, 2014 VIA ELECTRONIC MAIL, JULY 30, 2014, AUGUST 7, 2014 VIA A TELECONFERENCE CALL WITH ATTENDEES FROM THE USER FACILITY AND OLYMPUS, AUGUST 12, 2014, AUGUST 14, 2014, AUGUST 20, 21, 22, 2014. ON AUGUST 27, 2014, THE USER FACILITY DECLINED THE ON-SITE VISIT THAT OLYMPUS OFFERED IN AN ATTEMPT TO COLLABORATE ON A PHYSICAL INSPECTION OF ALL THE DUODENOSCOPES INVOLVED IN THE REPORTED EVENTS. OLYMPUS PERFORMED AN INVENTORY SEARCH FOR DEVICES SOLD TO THE USER FACILITY BASED ON THE NEWS ARTICLE DATED JANUARY 21, 2015 AND DETERMINED THE USER FACILITY HAD FIVE (5) TJF-160VF AND 23 TJF-Q180V. BASED ON THE HIGHER PROBABILITY THAT A 180 MODEL WAS USED ON THE REPORTED EVENTS, OLYMPUS SUPPLEMENTED THE 37 MDRS CHANGING THE DUODENOSCOPE MODEL FROM TJF-160VF TO TJF-Q180V. HOWEVER, THE SPECIFIC MODEL OF DUODENOSCOPES USED DURING THE REPORTED EVENTS STILL REMAINS UNK, AS THE USER FACILITY HAS NOT RESPONDED TO OLYMPUS' INQUIRIES.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED OF 37 ALLEGED INFECTIONS AT THE USER FACILITY INVOLVING MULTIPLE DUODENOSCOPES (160 SERIES/180 SERIES). IN EARLY 2013 THE WASHINGTON STATE DEPARTMENT OF HEALTH IDENTIFIED SEVEN CASES OF CARBAPANEM RESISTANT ENTEROBACTERIACEAE (CRE) CULTURES FROM SAMPLES SENT BY THE USER FACILITY. THERE WERE NO SPECIFIC ENDOSCOPE MODELS OR SERIAL NUMBERS PROVIDED BY THE USER FACILITY. FOUR DEATHS WERE IDENTIFIED BY THE USER FACILITY. THE CAUSE OF PATIENT DEATHS IS UNKNOWN. ADDITIONALLY, OLYMPUS WAS NOTIFIED OF 30 PATIENT INFECTIONS BASED ON CULTURES OF VARIANT E.COLI FROM PATIENT'S BLOOD, BITE, URINE, OR THE RESPIRATORY TRACT. OLYMPUS CONTACTED THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENTS BUT NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508255 OLYMPUS DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEM CORPORATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TJF-Q180V SERIAL NUMBER: UNK