BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8834452 · Received July 27, 2019

    Report

    Report Number
    9610877-2019-01384
    Event Type
    Malfunction
    Date Received
    July 27, 2019
    Report Date
    June 27, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY CROSS CHECKED THEIR RECORDS AND THERE ARE POTENTIALLY 14 PATIENTS THAT HAD PROCEDURES WHERE THE FORWARD WATER JET(FWJ) CHANNEL WENT THROUGH AN ENDOSCOPE WASHER DISINFECTOR(EWD) WHERE THE FWJ WOULD HAVE BEEN POTENTIALLY MISSED FOR A TOTAL OF14 PROCEDURES. A SEPARATE MDR IS BEING FILED FOR EACH OF THESE PROCEDURES. A TOTAL OF 14 MDRS ARE BEING SUBMITTED FOR THE TOTAL 14 PATIENT CASES IDENTIFIED FOR THE PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG29-I10, SERIAL NUMBER (B)(4). 9610877-2019-00361, 9610877-2019-01377 THRU 9610877-2019-01389. (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT ON 27JUN2019 THAT OCCURRED IN (B)(4). THE REPORTED COMPLAINT, "RED FLUID HAS BEEN DETECTED ON THE PILLOW OF A PATIENT DURING THE PREPARATION OF AN EXAMINATION WITH A DEMO GASTROSCOPE" INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG29-I10, SERIAL NUMBER (B)(4). COMPLAINT (B)(4) WAS CREATED FOR THE LOCAL INVESTIGATION OF THIS ISSUE IN (B)(4). ON (B)(6) 2019 WHILE PREPARING FOR A PROCEDURE THE VIDEO GASTROSCOPE MODEL EG29-I10, SERIAL NUMBER (B)(4) WAS ATTACHED TO THE PROCESSOR AND WHILE THE NURSE WAS ADJUSTING THE BED HEIGHT ACCIDENTALLY PRESSED THE FOOTSWITCH FOR THE EGA-500P, WHICH IS THE IRRIGATION PUMP PROVIDED ON THE PENTAX MEDICAL WORKSTATION. THIS MOMENTARILY ACTIVATED THE FORWARD WATER JET. NO ONE WITNESSED ANY FLUID COMING OUT OF THE GASTROSCOPE. WHEN THE IRRIGATION PUMP WAS ACTIVATED AGAIN, FLUID SPRAYED FROM THE FORWARD WATER JET ONTO THE NURSES. AT THIS TIME, THEY ALSO SAW RED FLUID ON THE PILLOW, HOWEVER, THEY DID NOT SEE ANY RED FLUID ON THE NURSES. THE SOURCE OF THE RED FLUID WAS UNCLEAR. AS THE STAFF WERE FOCUSED ON THE PATIENT, THE GASTROSCOPE WAS REMOVED FROM THE PROCESSOR BY THE PENTAX MEDICAL CLINICAL APPLICATIONS SPECIALIST AND THE ROOM WAS RE-PREPARED BY THE NURSES. THE PROCEDURE WAS COMPLETED WITH ANOTHER PENTAX MEDICAL GASTROSCOPE, UNKNOWN MODEL AND SERIAL NUMBER. THE GASTROSCOPE WAS TRANSFERRED TO THE DECONTAMINATION UNIT AND IMAGED PRIOR TO BEING PROVIDED TO PENTAX MEDICAL FOR EVALUATION. BASED ON THE QUESTIONING, TO OUR KNOWLEDGE, NO-ONE WITNESSED RED FLUID COMING FROM THE PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG29-I10, SERIAL NUMBER (B)(4). THERE HAVE BEEN NO REPORTS OF PATIENT INFECTION OR DEATH FROM THIS INCIDENT. DISCUSSIONS OF THE DECONTAMINATION PROCESS WITH THE USER FACILITY COVERING THE GASTROSCOPE'S POST PROCEDURE MANUAL CLEANING, LEAK TESTING, ENDOSCOPE WASHING DISINFECTOR (EWD) USE AND PRE-USE FLUSHING WERE PERFORMED AND ACCORDING TO INVESTIGATION NOTES "THE MANUAL FLUSHING HAD BEEN FOLLOWED BARRING USER ERROR", ALTHOUGH THE MANUAL FLUSHING AFTER THE LAST PREVIOUS PROCEDURE WAS NOT CONFIRMED. IT APPEARS THERE WAS AN ISSUE WITH THE CORRECT USE OF THE EWD BASED ON THE NUMBER OF CHANNELS THAT WERE REPROCESSED (4 RATHER THAN 5). THE PENTAX CLINICAL APPLICATIONS SPECIALIST SAID THAT THE USER FACILITY HAD BEEN ADVISED ON THE NUMBER OF CHANNELS THE GASTROSCOPE HAD BY THE PENTAX TERRITORY MANAGER BUT AS PENTAX (B)(4) EMPLOYEES, COULD NOT ADVISE ON THE CHANNEL CONNECTION WITHIN THE EWD. THIS NEEDED TO BE DEALT WITH BY EITHER (B)(4) EMPLOYEE, MANUFACTURER OF THE EWD. "ALL BAYS WERE CHECKED AND IT APPEARS THAT THE SCOPES TRAINED LAST WEEK AND AT THE START OF THE WEEK HAD BEEN TRAINED CORRECTLY BUT WHEN EITHER RE-DONE IN A MACHINE OR INTO MACHINE 4 WERE AUTO-APPRENTICED INCORRECTLY. ALL THE SCOPES TRAINED IN ON (B)(6) WERE INCORRECT ALTHOUGH IT APPEARS ONLY 2 WERE USED." BASED ON RECORDS REVIEWED BY PENTAX AND THE USER FACILITY THERE ARE POTENTIALLY 14 PATIENTS THAT HAD PROCEDURES WHERE THE FWJ CHANNEL WENT THROUGH AN EWD WHERE THE FWJ COULD HAVE BEEN MISSED. A TOTAL OF 14 MDRS ARE BEING SUBMITTED FOR THE TOTAL 14 PATIENT CASES IDENTIFIED FOR THE PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG29-I10, SERIAL NUMBER (B)(4). 9610877-2019-00361, 9610877-2019-01377 THRU 9610877-2019-01389. ON JULY 3, 2019, THE PENTAX (B)(4) HEAD OF MARKETING, STATED THAT VIDEO GASTROSCOPE MODEL EG29-I10, SERIAL NUMBER (B)(4) WAS IN PENTAX'S POSSESSION AND HAS BEEN EVALUATED. THE GASTROSCOPE WAS BRUSHED, FLUSHED, CLEANED AND IMAGED AFTER EACH STEP AS REQUESTED BY THE EMEA COMPLAINT HANDLING UNIT. NO VISIBLE RESIDUE ON FLUSH OR BRUSHING WAS FOUND. THERE ARE NO DEFECTS DETECTED ON THE GASTROSCOPE. PENTAX (B)(4) CLOSED THE COMPLAINT AS AN UNKNOWN ROOT CAUSE AND THE OVERALL COMPLAINT AS INVALID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628288 PENTAX VIDEO GASTROSCOPE - I10 STANDARD FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10

    Patients

    Seq Age Sex Outcome Treatment
    1