BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9305111 · Received November 11, 2019

    Report

    Report Number
    9610877-2019-01542
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 15, 2019
    Report Date
    October 29, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K161222
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT ON (B)(6) 2019 STATING PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER (B)(4), YIELDED A HIGH CONCERN BACTERIUM AFTER SAMPLING PERFORMED ON (B)(6) 2019. THE SAMPLING PERFORMED ON (B)(6) 2019 IDENTIFIED 18 COLONY FORMING UNITS(CFU) AS COMPRISING OF THE FOLLOWING 5 ISOLATES: 1 - POSITIVE COCCI - KYTOCOCCUS SCHROETERI, 2 - POSITIVE COCCI - STAPHYLOCOCCUS HAEMOLYTICUS, 3 - POSITIVE COCCI - STAPHYLOCOCCIS LUGDUNENSIS, 4 - POSITIVE RODS - PAENIBACILLUS SPECIES, 5 - POSITIVE COCCI - MICROCOCCUS LUTEUS/ M. YUNNANENSIS. STUDY NUMBER: 1231743. THE LONG TERM LOANER DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON (B)(6) 2019. THE DUODENOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON (B)(6) 2019 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: DISTAL CAP/ CASE CRACKED, DISTAL CAP - FIXED TYPE PASSED EPOXY SEAL INTEGRITY INSPECTION, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY. A DEVICE HISTORY RECORD(DHR) WAS PREVIOUSLY PERFORMED ON (B)(6) 2019 UNDER FORM NUMBER IVAI-19-090007. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 10-JUL-2015 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 FOR (B)(6) 2015. PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2015. THE VIDEO DUODENOSCOPE IS AWAITING REPAIRED AND ORGANIC RESAMPLING AS OF (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099234 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1