BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 5814110 · Received July 21, 2016

    Report

    Report Number
    9610877-2016-00140
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Report Date
    November 11, 2015
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PENTAX VIDEO COLONOSCOPE MODEL EC38-I10F2 IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. THIS MDR WAS INITIATED AS PART OF A CAPA-DRIVEN REMEDIATION EFFORT RELATED TO FILING OF MDRS 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

    HOYA CORPORATION PENTAX (B)(4) OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. (B)(4) PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B)(4). (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 (B)(6) LABORATORY FOUND 5 KBE/ML APATHOGENE B. DURING FLUSH TESTING OF THE BIOPSY CHANNEL, INVOLVING PENTAX MODEL EC38-I10F2/SERIAL (B)(4). ADDITIONAL INFORMATION FROM PENTAX EUROPE STATED PENTAX EUROPE ALSO CLEANED AND TESTED THE ENDOSCOPE AND OBTAINED THE SAME RESULT. ONCE REPAIRS ARE COMPLETED, PENTAX EUROPE WILL CLEAN AND TEST THE ENDOSCOPE AGAIN.

    Description of Event or Problem · 0

    REPAIRS WERE COMPLETED ON THE COLONOSCOPE. SAMPLING PERFORMED ON (B)(6) 2016 AFTER REPROCESSING TESTED NEGATIVE. ON 06-FEB-2018, 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
    465930 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10F2

    Patients

    Seq Age Sex Outcome Treatment
    1