BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G244026 EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 12296971 · Received August 9, 2021

    Report

    Report Number
    8010047-2021-09983
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Report Date
    October 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170433498
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO PROVIDE INVESTIGATION FINDINGS. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE(S) COULD NOT BE REVIEWED SINCE THE MODEL NUMBER(S) WERE NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. CONCLUSION: THE DEFINITIVE CAUSE OF THE REPORTED EVENTS COULD NOT BE ESTABLISHED. NO INFORMATION WAS PROVIDED REGARDING REPROCESSING OF THE SUBJECT DEVICE. NO INFORMATION WAS PROVIDED REGARDING THE LOCATION WHERE MICROORGANISM WAS DETECTED.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER: THE STUDY LISTS PJF-160, JF-140F, TJF-160F, TJF-160VF, AND TJF-Q180V AS THE DEVICES IN THE SAMPLING AND CULTURING STUDY. PJF-160 WAS ENTERED IN THIS FIELD. ANY OF THESE LISTED DEVICES COULD HAVE BEEN INVOLVED (NO SPECIFIC INFORMATION WAS PROVIDED). THE DEVICE(S) REFERENCED IN THIS REPORT HAVE NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED IN THE LITERATURE TITLED "ENDOSCOPIC TRANSMISSION OF CARBAPENEM-RESISTANT ENTEROBACTERIACEAE: IMPLICATIONS FOR FOOD AND DRUG ADMINISTRATION APPROVAL AND POSTMARKET SURVEILLANCE OF ENDOSCOPIC DEVICES", OLYMPUS SCOPES HAD POSITIVE CULTURES AFTER REPROCESSING. THE STUDY PRESENTED AN OVERVIEW OF THE FDA APPROVAL OF DUODENOSCOPES BY ANALYZING FDA¿S 510(K) PREMARKET NOTIFICATION DATABASE FOR DATA SUPPORTING CLEARANCE OF DUODENOSCOPE MODELS IMPLICATED IN CARBAPENEM-RESISTANT ENTEROCOCCUS (CRE)-RELATED OUTBREAKS, AS WELL AS SUBSEQUENTLY REQUIRED POSTMARKET STUDIES. THE STUDY ADDRESSED THE POLICY IMPLICATIONS OF CRE OUTBREAKS ON POSTMARKETING SURVEILLANCE AND THE NEED FOR INCREASED GASTROENTEROLOGIST INVOLVEMENT IN THE LIFECYCLE OF DUODENOSCOPES AND OTHER MEDICAL DEVICES. THE STUDY INCLUDED REPORTING THOROUGH ADVERSE EVENT DATA TO FDA AND DEVICE MANUFACTURERS, AS WELL AS SUPPORTING ACTIVE SURVEILLANCE STUDIES TO ENSURE SAFETY AND EFFECTIVENESS AND EVALUATING IMPLEMENTATION OF RECOMMENDATIONS TO REDUCE ADVERSE EVENTS. AN ONGOING SAMPLING AND CULTURING STUDY INVOLVING OLYMPUS PJF-160, JF-140F, TJF-160F, TJF-160VF, AND TJF-Q180V SCOPES WAS REFERENCED. THE PRELIMINARY DATA SHOWED 75 OF 1488 CULTURES PERFORMED AFTER REPROCESSING WERE POSITIVE FOR HIGH CONCERN MICROORGANISMS. SPECIFIC DATA IS NOT PROVIDED REGARDING EACH CULTURE PERFORMED, OR METHODS OF REPROCESSING USED. THERE IS NO REPORTED PATIENT IMPACT RELATED TO ANY OF THESE CULTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195237 G244026 EVIS EXERA DUODENOVIDEOSCOPE DUODENO VIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. PJF-160 04953170433498

    Patients

    Seq Age Sex Outcome Treatment
    1