BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 5716250 · Received June 9, 2016

    Report

    Report Number
    9610877-2016-00118
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Report Date
    May 10, 2016
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015036).

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    A LABORATORY REPORT RECEIVED BY PENTAX MEDICAL FROM (B)(4), A LABORATORY OF TOXICOLOGICAL, MICROBIAL AND MOLECULAR DIAGNOSTICS, INDICATED AFTER TESTING VARIOUS SAMPLE MATERIALS OBTAINED FROM PENTAX MODEL EC38-I10L/SERIAL (B)(4), "NO CRITICAL PATHOGENS" COULD BE DETECTED. THE REPORT ALSO STATED, "THE GUIDELINE VALUES HAVE BEEN COMPLIED WITH. THE SAMPLES EXAMINED THUS CORRESPOND TO HYGIENIC-MICROBIOLOGICAL REQUIREMENTS."

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN (B)(6) INVOLVING A NEW AND PREVIOUSLY UNUSED PENTAX MODEL EC38-I10L/SERIAL (B)(4). THE REPORT STATED, BEFORE THE FIRST USE, THE DEVICE WAS REPROCESSED IN THE CUSTOMER'S RDG-E (WITHOUT MANUAL BRUSHING) AND SAMPLED. THE REPORT ALSO STATED "IT WAS FOUND A CFU OF 100 AEROBIC SPORE FORMERS IN INSTRUMENTATION CHANNEL. ALL EXISTING RENTAL UNITS MADE BY PENTAX AND ALSO THE SECOND NEW UNIT SHIPPED TESTED NEGATIVE. THERE WAS ALSO A FINAL WATER SAMPLING OF RDG-E USED CARRIED OUT - ALSO WITHOUT FINDINGS". A LABORATORY REPORT RECEIVED BY PENTAX MEDICAL FROM (B)(6), A MEDICAL LABORATORY IN (B)(6) INDICATED THE FOLLOWING CULTURE RESULTS: "PENTAX COLONOSCOPE EC38-I 10L, (B)(4); SMEAR DIST. END CULTURE (SMEAR) NEGATIVE. PENTAX COLONOSCOPE EC38-I 10L, (B)(4); AIR / WATER CHANNEL BIOBURDEN 1 CFU / ML. CULTURE (RINSE) STAPH.EPIDERMIDIS - GROUP ((B)(4)) INHIBITORS ANTIBACTERIALS NOT DETECTED. PENTAX COLONOSCOPE EC38-I 10L, (B)(4); INSTRUMENTATION CHANNEL BIOBURDEN 100 CFU / ML. CULTURE (RINSE) AEROBIC SPORE INHIBITORS ANTIBACTERIALS NOT DETECTED. PENTAX COLONOSCOPE EC38-I 10L, (B)(4); ADDITIONAL FLUSHING CHANNEL BIOBURDEN <1 CFU / ML. CULTURE (RINSE) NEGATIVE. INHIBITORS ANTIBACTERIALS NOT DETECTED". PENTAX EUROPE (B)(4) IS CURRENTLY INVESTIGATING THIS EVENT.

    Additional Manufacturer Narrative · 1

    HOYA CORPORATION PENTAX (B)(4) OFFICE, SPECIFICATION DEVELOPER, (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 1

    ON 25-OCT-2016, A DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING THE COLONOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, THEREFORE, PENTAX CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369629 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L

    Patients

    Seq Age Sex Outcome Treatment
    1