BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 10624536 · Received October 4, 2020

    Report

    Report Number
    9610877-2020-00164
    Event Type
    Malfunction
    Date Received
    October 4, 2020
    Report Date
    December 8, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333232420
    PMA / PMN Number
    K161222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THREE FAILED ATP TESTS AFTER ENDOSCOPE REPROCESSING REPORTED POSSIBLE CONTAMINATION. HOWEVER, THE ATP TEST IS A MEASURE OF CLEANLINESS AND COULD NOT CONFIRM BACTERIAL OR VIRAL CONTAMINATION. THE DHR STATED THAT IT PASSED ALL REQUIRED ] OBTAIN CULTURE TEST RESULTS IN NOVEMBER 2022. IT WAS CONFIRMED THAT THERE WAS NO RISK OF INFECTION (R&D REVIEWED). THE CAUSE OF THE FAILURE IN THE ATP TEST COULD NOT BE IDENTIFIED. CORRECTION INFORMATION: H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON 04-SEP-2020 THAT OCCURRED AFTER REPROCESSING IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THERE IS POTENTIAL ENDOSCOPE CONTAMINATION AS THE ENDOSCOPE FAILED ADENOSINE TRIPHOSPHATE(ATP) TEST 3 TIMES AFTER REPROCESSING, INVOLVING PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER H110912. NO PATIENT INVOLVEMENT WAS REPORTED. THE VIDEO DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 14-SEP-2020. THE VIDEO DUODENOSCOPE IS CURRENTLY AWAITING REPAIR, AND ORGANIC SAMPLING AS OF (B)(6) 2020. ON 22-SEP-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL ED- 3490TK, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER IVAI-20-090019, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 28-JAN-2016 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 28-JAN-2016. PENTAX MEDICAL, MODEL ED-3490TK, SERIAL NUMBER (B) (4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2016. THE INVESTIGATION IS IN-PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089243 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK 04961333232420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown