BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 5814129 · Received July 21, 2016

    Report

    Report Number
    9610877-2016-00148
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Report Date
    April 12, 2016
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).. THIS MDR WAS INITIATED AS PART OF A CAPA-DRIVEN REMEDIATION EFFORT RELATED TO FILING OF MDR'S FOR COMPLAINTS/EVENTS OUTSIDE OF THE US (OUS). AS PART OF THIS REMEDIATION, PENTAX MEDICAL PERFORMED A RETROSPECTIVE MDR ASSESSMENT OF ALL OUS EVENTS/COMPLAINTS RECEIVED SINCE OCTOBER 2015. THE RETROSPECTIVE ASSESSMENT OF THIS EVENT PROMPTED PENTAX MEDICAL TO FILE THIS REPORT. (EXEMPTION NUMBER E2015036).

    Additional Manufacturer Narrative · 0

    REPORT SOURCE CONTINUED: HOYA CORPORATION PENTAX TOKYO OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX TOKYO OFFICE (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN (B)(6) STATING IN PREPARATION OF THE DEMONSTRATION ENDOSCOPE (PENTAX MODEL EG-3270UK/SERIAL (B)(4)) FOR THE LIVE SESSION AT (B)(6), THIS MODEL WAS FOUND TO BE COLONIZED BY BACTERIA AFTER INITIAL REPROCESSING AND THEREFORE WAS EXCLUDED FROM BEING USED.

    Description of Event or Problem · 0

    PENTAX MEDICAL REQUESTED REPROCESSING DETAILS FROM THE CUSTOMER. NO REPROCESSING DETAILS WERE RECEIVED. THE DEVICE WAS RETURNED TO PENTAX EUROPE WHERE REPROCESSING AND SAMPLING WAS PERFORMED. THE RESULTS OF THE SAMPLING CONFIRMED THE REPROCESSING WAS NOT SUCCESSFUL. PENTAX EUROPE REPLACED THE CHANNEL SYSTEMS ON THE DEVICE. ON 06-FEB-2018, A DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING THE VIDEO GASTROSCOPE 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. SINCE NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, PENTAX MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465703 PENTAX ULTRASOUND VIDEO GASTROSCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG-3270UK

    Patients

    Seq Age Sex Outcome Treatment
    1