BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 10901142 · Received November 25, 2020

    Report

    Report Number
    9610877-2020-00251
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    December 5, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS IS AN EVENT IN WHICH A FOREIGN MATTER SUCH AS A BRUSH CLOGS THE PIPE. THE CAUSE IS THOUGHT TO BE THAT THE BRUSH USED BY THE USER DURING CLEANING WAS BROKEN AND REMAINED IN THE PIPE. ADDITIONAL INFORMATION H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 1

    (B)(4). MDR 9610877-2020-00234 IS BEING SUBMITTED FOR THE PENTAX MEDICAL VIDEO ESOPHAGEOSCOPE, MODEL EE-1580K, SERIAL NUMBER H110515. MDR 9610877-2020-00251 IS BEING SUBMITTED FOR THE PENTAX MEDICAL CLEANING BRUSH, MODEL CS6021T, UNKNOWN SERIAL NUMBER.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 26-OCT-2020 REGARDING "ACCESSORY STUCK IN SCOPE" DURING REPROCESSING, INVOLVING PENTAX MEDICAL VIDEO ESOPHAGEOSCOPE, MODEL EE-1580K, SERIAL NUMBER (B)(4). THE REPORTING END USER STATED THAT THEY EXPERIENCED THE FAILURE DURING REPROCESSING. NO PATIENT INVOLVEMENT WAS REPORTED. THE REPORTER RESPONDED VIA PHONE AND EMAIL TO GOOD FAITH EFFORT ATTEMPTS ON 19-NOV-2020 AND STATED THAT HE "SPOKE WITH THE REPROCESSING PERSONNEL AND THEY TOLD ME[THE REPORTER] IT WAS A CLEANING SCOPE BRUSH PRODUCT NUMBER CS-6021T. WHEN I PACKED THE SCOPE TO SEND IT TO YOU GUYS I COULD SEE A PART OF THE BRUSH STICKING OUT OF THE DISTAL END.". THE P{ENTAX MEDICAL CLEANING BRUSH ACCESSORY MODEL CS-6021T, UNKNOWN SERIAL NUMBER WAS NOT RETURNED WITH THE ENDOSCOPE FOR EVALUATION. INSTRUCTIONS FOR USE(IFU), INCLUDES THE FOLLOWING WARNING SECTION "AFTER USING OPERATIONAL/CLEANING ACCESSORIES (E.G., FORCEPS, NEEDLES, SNARES, BRUSHES ETC.) WITH THE ENDOSCOPE, CAREFULLY CHECK THAT ALL ACCESSORIES ARE INTACT AND THAT NO PARTS HAVE FALLEN OFF AND BECOME LODGED WITHIN THE ENDOSCOPE'S INSTRUMENT/SUCTION CHANNEL. FURTHERMORE, ENSURE THAT ANY THERAPEUTIC DEVICES (E.G., CLIPS, STENTS, ETC.) PASSED THROUGH THE CHANNEL ARE ACCOUNTED FOR AFTER USE. ON 06-APR-2016, PENTAX ISSUED A U.S. URGENT FIELD CORRECTION WHICH IS AN IFU ADDENDUM FOR ENDOSCOPES WITH INSTRUMENT CHANNELS. THIS ADDENDUM COVERS ANY OPERATIONAL/CLEANING ACCESSORIES AND THERAPEUTIC DEVICES WHICH CAN BECOME LODGED IN THE ENDOSCOPE'S INSTRUMENT CHANNEL. IT REMINDS CUSTOMERS TO CAREFULLY CHECK THAT ALL ACCESSORIES ARE INTACT, THAT NO PARTS HAVE FALLEN OFF AND BECOME LODGED WITHIN THE ENDOSCOPE'S INSTRUMENT/SUCTION CHANNEL AND TO ENSURE THAT ANY THERAPEUTIC DEVICES (E.G., CLIPS, STENTS, BALLOONS, ETC.) PASSED THROUGH THE INSTRUMENT CHANNEL AND ARE ACCOUNTED FOR AFTER USE. INVESTIGATION IN-PROCESS S OF 24-NOV-2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372170 PENTAX CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS-6021T UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown