BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11719505 · Received April 23, 2021

    Report

    Report Number
    9610877-2021-00100
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    August 19, 2020
    Report Date
    August 19, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. (B)(4). MDR IS ADDRESSING DISTAL END CAPS(DEC) MODEL OE-A63, LOT NUMBER 0011029 USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4). MDR 9610877-2021-00101 IS ADDRESSING DISTAL END CAPS(DEC) MODEL OE-A63, LOT NUMBER 0011029 USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED IN THE OPERATING ROOM BEFORE USE IN THE UNITED STATES. THE PENTAX MEDICAL SALES REP REPORTED THAT WHILE ON SITE ON (B)(6) 2020, AND IN THE OPERATING ROOM PRIOR TO THE PROCEDURE AND BEFORE A PATIENT WAS IN THE ROOM, THE SALES REP ASSISTED TRYING TO ATTACH A DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011029 ONTO PENTAX MEDICAL DEMO VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4). AFTER HEARING THE DEC CLICK INTO PLACE, THE ELEVATOR CONTROL MECHANISM WOULD NOT RETURN TO THE NEUTRAL POSITION, REGARDLESS OF THE POSITION OF THE INSERTION FLEXIBLE TUBE(IFT). A SECOND DEC WAS TRIED FROM THE SAME LOT AND ALSO DID NOT WORK AS EXPECTED. A SECOND VIDEO DUODENOSCOPE WAS BROUGHT INTO THE ROOM. MODEL ED34-I10T2, SERIAL NUMBER (B)(4) WAS TRIED WITH TWO SEPARATE DISTAL END CAPS(DEC) MODEL OE-A63, LOT NUMBER 0011029. NEITHER OF THE ELEVATOR CONTROL MECHANISMS WOULD NOT RETURN TO THE NEUTRAL POSITION. THE DEMO UNIT ENDOSCOPE WAS RETURNED TO PENTAX MEDICAL ON 27-AUG-2020. THE DISTAL END CAPS WERE NOT RETURNED. ON 23-APR-2021, A DEVICE HISTORY RECORD(DHR) REVIEW FOR PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER IVAI-21-040032, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 05-FEB-2020 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 05-FEB-2020. THE INVESTIGATION IS IN-PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614377 PENTAX STERILE DISTAL END CAP WITH ELEVATOR FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0011029

    Patients

    Seq Age Sex Outcome Treatment
    1