BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 10410760 · Received August 14, 2020

    Report

    Report Number
    9610877-2020-00107
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    June 24, 2020
    Report Date
    July 15, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333232598
    PMA / PMN Number
    K182004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON 15-JUL-2020 PENTAX MEDICAL RECEIVED A CUSTOMER REPORT STATING VIDEO PROCESSOR, MODEL EPK-I5010, SERIAL NUMBER (B)(4) WAS INVOLVED IN A MALFUNCTION EVENT. THE USER REPORTED "NO IMAGE- SCOPE CUTS OUT DURING PROCEDURE THAT LEAD TO MEDICAL INTERVENTION OF ADDITIONAL ANESTHESIA AND A POSSIBLE DELAY THAT PUT THE PATIENT AT RISK FOR ADVERSE EVENTS." THE USER FACILITY RESPONDED TO A GOOD FAITH EFFORT(GFE) ATTEMPT VIA EMAIL ON 15-JUL-2020 AND NOTED THE REPORTED NO IMAGE OCCURRED DURING A TREATMENT PROCEDURE ON (B)(6) 2020. THERE WAS NO INJURY REPORTED, BUT THERE WAS A DELAY IN THE PROCEDURE WHICH RESULTED IN ADDITIONAL ANESTHESIA WHICH THE USER FELT POSSIBLY PUT THE PATIENT AT RISK FOR AN ADVERSE EVENT, ALTHOUGH NONE WERE REPORTED. THE PRODUCT REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACE. THE PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED BY THE USER. THE CUSTOMER OWNED PROCESSOR WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 14-JUL-2020. THE VIDEO PROCESSOR WAS EVALUATED AND AFTER THREE DAYS OF TESTING THE SERVICE REPAIR TECHNICIAN WAS UNABLE TO REPRODUCE THE CUSTOMERS REPORTED EXPERIENCE. SINCE THE USER CONTACT STATED THAT THE CONTROL PANEL IS NOT LIGHTING UP AND BUTTONS ARE NOT RESPONDING THE SERVICE TEAM REPLACED THE SBS BOARD AS A PREVENTATIVE MEASURE AND DOCUMENTED THAT THE SBC PCB TOUCH PANEL CONTROLS NOT FUNCTIONING. ON 28-JUL-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EPK-I5010, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER IVAI-20-070084, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 01-OCT-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 01-OCT-2015. PENTAX MEDICAL MODEL EPK-I5010, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2015. THE VIDEO PROCESSOR WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(6) 2020 UNDER DELIVERY NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870158 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I5010 04961333232598

    Patients

    Seq Age Sex Outcome Treatment
    1