BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12096332 · Received June 30, 2021

    Report

    Report Number
    9610877-2021-00103
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    February 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) MDR 9610877-2021-00102 WILL BE SUBMITTED FOR THE PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG16-K10, SERIAL NUMBER (B)(4). MDR 9610877-2021-00103 WILL BE SUBMITTED FOR THE PENTAX MEDICAL CLEANING BRUSH MODEL CS-6021T, UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF AN EVENT ON 25-FEB-2021 THAT OCCURRED IN (B)(6). THE REPORTED COMPLAINT OF "FORCEPS MOUTH BRUSH CLOGGING", INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG16-K10, SERIAL NUMBER (B)(4) DID NOT CONTRIBUTE TO OR CAUSE A SERIOUS INJURY OR DEATH OF A PATIENT OR USER. PENTAX MEDICAL (B)(4) PERFORMED GOOD FAITH EFFORT TO THE USER AND CONFIRMED THE ENDOSCOPE WAS USED DURING THE PROCEDURE, AND THERE WAS NO DELAY IN THE PROCEDURE WHICH MEDICAL INTERVENTION WAS REQUIRED. THERE WAS RESISTANCE FELT DURING REPROCESSING AND THEN THE CLEANING BRUSH BECAME STUCK IN THE CHANNEL. ON 30-APR-2021, PENTAX MEDICAL (B)(4) RESPONDED TO AN EMAIL REQUEST FOR ADDITIONAL INFORMATION. THEY RESPONDED STATING THAT THE PENTAX MEDICAL CLEANING BRUSH MODEL CS-6021T, UNKNOWN LOT NUMBER, WAS DAMAGED AND CLOGGED DURING REPROCESSING. INSTRUCTIONS FOR USE(IFU), INCLUDES THE FOLLOWING WARNING SECTION 2-1-3, 3) "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. ON 9-MAR-2021, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EG16-K10, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER (B)(4), THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 18-SEP-2012 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 18-SEP-2012. A DEVICE HISTORY RECORD(DHR) REVIEW COULD NOT BE COMPLETED FOR FOR PENTAX MEDICAL CLEANING BRUSH MODEL CS-6021T AS THE LOT NUMBER IS UNKNOWN. DURING EVALUATION OF THE RETURNED ENDOSCOPE, A CLEANING BRUSH (CS-6021T) WAS FOUND STACKED AT THE ENTRANCE OF THE FORCEPS OPENING. THE INSTRUCTIONS FOR USE(IFU) STATES THAT THE FORCEPS OPENING SHOULD BE CLEANED USING CS-C9S, BUT THIS OCCURRED BECAUSE CS-6021T WAS INSERTED. THE ENDOSCOPE WAS REPAIR AND APPROVED ON 19-MAY-2021..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987348 PENTAX CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS-6021T UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1