BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 5740978 · Received June 22, 2016

    Report

    Report Number
    8010047-2016-00831
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Report Date
    October 21, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS COULD NOT DETERMINE WHETHER OR NOT THE DEVICES REFERENCED IN THIS REPORT WERE RETURNED TO OLYMPUS FOR EVALUATION AT THIS TIME. ADDITIONALLY, OLYMPUS COULD NOT DETERMINE WHETHER OR NOT THERE WAS DEVIATION OF REPROCESSING PRACTICE IN THE USER FACILITIES. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO UPDATE THE DESCRIBED EVENT FOR TJF-Q180V MODELS WITH MORE SPECIFIC INFORMATION THAN WAS FIRST DESCRIBED IN A LETTER ISSUED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO UPDATE THE DESCRIBED EVENT FOR TJF-Q180V MODELS WITH THE LATEST INFORMATION. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION TO INVESTIGATE THESE COMPLAINTS HAVE BEEN MADE BUT WITH NO RESULTS.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED OF A LETTER TITLED "REGARDING PRELIMINARY RESULTS PROCESS STUDY". OLYMPUS MEDICAL SYSTEMS CORP OBTAINED AN ENGLISH TRANSLATION OF THE LETTER. THE LETTER STATED: "ALL (B)(6) CENTERS WERE REQUESTED TO SAMPLE AT LEAST TWO CLEANED AND DISINFECTED DUODENOSCOPES IN ACCORDANCE WITH A UNIFORM COLLECTION METHOD. IF TYPE OLYMPUS TJF-Q180V WAS AVAILABLE, A SAMPLE FROM THIS TYPE WAS REQUESTED. THE SAMPLES WERE CULTIVATED AT A CENTRAL LOCATION; (B)(6). A DUODENOSCOPE WAS CONSIDERED CONTAMINATED IF THE COLLECTION SITE WAS CONTAMINATED WITH EQUAL TO OR GREATER THAN 1 MICROORGANISM WITH EQUAL TO OR GREATER THAN 20 COLONY-FORMING UNITS (CFU). SOMETIMES, THE DEFINITION USED IS STRICTER: "ANY GROWTH OF INTESTINAL FLORA IS CONSIDERED POSITIVE; INCLUDING EQUAL TO OR GREATER THAN1 CFU IN 1 SAMPLE". ACCORDING TO THE LETTER, BETWEEN JUNE 2015 AND MARCH 2016, 96% (67/73) OF THE (B)(6) CENTERS SUBMITTED SAMPLES OF 148 DUODENOSCOPES IN TOTAL. TEN TYPES OF DUODENOSCOPES FROM ALL THREE MANUFACTURERS - OLYMPUS, PENTAX AND FUJIFILM - WERE REPRESENTED. THE LETTER MENTIONED "22% (33/148) OF DUODENOSCOPES SHOWED CONTAMINATION IN ACCORDANCE WITH THE DEFINITION AS APPLIED BY US. CONTAMINATION PROVED NOT TO BE TYPE-DEPENDENT. BETWEEN THE ANALYZED DUODENOSCOPES, NONE DIFFERED SIGNIFICANTLY FROM THE REFERENCE TYPE. THE DUODENOSCOPES WERE MAINLY CONTAMINATED WITH SKIN FLORA AND INTESTINAL FLORA, A TOTAL OF 12% (18/148) AND 11% (17/148) RESPECTIVELY. CONTAMINATION WITH INTESTINAL FLORA WAS FOUND IN SEVERAL TYPES OF DUODENOSCOPES. THIS WAS ALSO NOT TYPE-DEPENDENT IN THE ANALYZED DUODENOSCOPES. IF THE STRICTER DEFINITION WOULD BE APPLIED, (EQUAL TO OR GREATER THAN 1-20 CFU INTESTINAL FLORA IS ALSO POSITIVE), THEN 18% (27/148) OF THE DUODENOSCOPES WERE CONTAMINATED WITH INTESTINAL FLORA. AT THE TIME OF THIS STUDY, 39% (26/67) OF THE (B)(6) CENTERS HAD EQUAL TO OR GREATER THAN 1 DUODENOSCOPE THAT WAS CONTAMINATED READY FOR PATIENT USE. DEPENDING ON THE DEFINITION, EITHER 21% (14/67) OR 28% (19/67) OF ALL CENTERS HAD EQUAL TO OR GREATER THAN 1 DUODENOSCOPE INFECTED WITH INTESTINAL FLORA." THE LETTER'S CONCLUSIONS REGARDING THIS STUDY STATES: "PROCESS CONTROL DOSE NOT OFFER A GUARANTEE TO PREVENT CONTAMINATED DUODENOSCOPES FROM BEING USED" THERE IS NO INFORMATION ON THE NUMBER OF TJF-Q180V THAT SHOWED CONTAMINATION. HOWEVER, OLYMPUS IS SUBMITTING 33 MDRS TO ACCOUNT FOR 33 DUODENOSCOPES REPORTEDLY CONTAMINATED. THERE WERE NO PATIENT INFECTIONS REPORTED. THIS IS REPORT 2 OF 33.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A PRESENTATION MATERIAL DATED MAY 25, 2016, WHICH INDICATES ADDITIONAL INFORMATION. ACCORDING TO THE PRESENTATION MATERIAL, TOTAL 32 DUODENOSCOPES WERE CONTAMINATED IN ACCORDANCE WITH THE DEFINITION AS APPLIED BY THE USER FACILITY. FIFTEEN OUT OF THE 32 DUODENOSCOPES WERE REPORTED TO BE TJF-Q180V. THIRTEEN OUT OF THE 32 DUODENOSCOPES WERE REPORTED TO BE TJF-160VR OR TJF-160R WHICH ARE NOT MARKETED IN THE UNITED STATES. FOUR OUT OF THE 32 DUODENOSCOPES WERE REPORTED TO BE NOT MANUFACTURED BY OLYMPUS. WITH REGARD TO TJF-Q180V, TOTAL 57 SCOPES WERE CULTURED AND 15 OUT OF 57 (26%) SCOPES WERE REPORTED TO BE CONTAMINATED. NINE OUT OF THE 15 TJF-Q180V WERE REPORTED TO BE CONTAMINATED WITH GASTROINTESTINAL MICROORGANISMS. THIS IS REPORT 2 OF 33.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED PRESENTATION MATERIAL REPORTING ADDITIONAL INFORMATION. OLYMPUS HAD PREVIOUSLY REPORTED THAT 15 OUT OF 57 TJF-Q180V SCOPES WERE CONTAMINATED. THE PRESENTATION MATERIAL PROVIDES A NEW INFORMATION THAT TOTAL 67 TJF-Q180V WERE CULTURED AND 15 OUT OF THOSE 67 SCOPES (22%) WERE CONTAMINATED WITH GASTROINTESTINAL OR ORAL FLORA. SPECIFIC NAMES OF MICROORGANISMS HAVE NOT BEEN PROVIDED. ADDITIONALLY, THE PRESENTATION MATERIAL INDICATES THAT 15 SCOPES WERE TJF-Q180V, 14 SCOPES WERE TJF-160R/VR DEVICES NOT MARKETED IN THE UNITED SATES, AND 4 SCOPES WERE MARKETED BY OTHER MANUFACTURES. OLYMPUS HAD PREVIOUSLY REPORTED THE MODEL NAME OF THE SCOPES THAT WAS CONTAMINATED WITH UNSPECIFIED MICROORGANISMS AS FOLLOWS; 13 SCOPES WERE TJF-160R/VR AND ONE WAS UNSPECIFIED DUODENOSCOPE. BASED ON THE PRESENTATION MATERIAL, THESE 14 SCOPES WERE TJF-160R/VR. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. THIS IS REPORT 2 OF 33.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397685 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1