BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11886411 · Received May 26, 2021

    Report

    Report Number
    9610877-2021-00106
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    April 29, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333211692
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON (B)(6) 2021 THAT OCCURRED IN THE UNITED STATES. THE REPORTED COMPLAINT THAT A "BRUSH STUCK/BROKEN IN CHANNEL" INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG29-I10, SERIAL NUMBER (B)(4). THE USER FACILITY RESPONDED TO A GOOD FAITH EFFORT(GFE) REQUEST VIA EMAIL ON 05-MAY-2021 STATING THE EVENT OCCURRED DURING REPROCESSING AND THERE WERE NO PATIENT/USER INJURIES OR ADVERSE EVENTS REPORTED. THE CLEANING ACCESSORIES THAT BECAME STUCK INSIDE THE ENDOSCOPE WAS A GI SOURCE DOUBLE ENDED VALVE BRUSH MODEL 1008-C. THE ENDOSCOPE MODEL EG29-I10, SERIAL NUMBER (B)(4) WAS REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 06-MAY-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER 3133002 AND ALTHOUGH THE TECHNICIAN WAS UNABLE TO CONFIRM THE CUSTOMER'S COMPLAINT OF A STUCK ACCESSORY, THEY DID NOTE RESISTANCE IN THE SUCTION TUBE AND ALSO DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 06-MAY-2021: OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY, FAILED WET LEAK TEST, WATER NOZZLE GLUE MISSING, RIGHT/ LEFT KNOB STICKING, FAILED DRY LEAK TEST, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY, HOLE IN # 1 REMOTE CONTROL BUTTON COVER, FORWARD BODY COVER JOINT SEAL RING WORN OR LOOSE THREAD, LEAK AT # 1 REMOTE CONTROL BUTTON COVER. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, BENDING RUBBER, RL PULLEY ASSY, UD PULLEY ASSY, ADJUSTING COLLAR, ANGLE WIRE, OPERATION CHANNEL, SUCTION CHANNEL LG, REMOTE CONTROL BUTTON(1), JOINT SEAL RING, O-RING (1.8X19.8). THIS IS THE FIRST TIME PENTAX MEDICAL MODEL EG29-I10, SERIAL NUMBER (B)(4) HAS BEEN RETURNED FOR SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 31-DEC-2018. ON 24-MAY-2021, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EG29-I10, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER (B)(4), THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 21-NOV-2018 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. REWORK WAS PERFORMED TO REPLACE THE SUBSTRATE BUT THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 22-NOV-2018. 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. THE ENDOSCOPE IS AWAITING REPAIR AND APPROVED BY FINAL QC AS OF 24-MAY-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781705 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10 04961333211692

    Patients

    Seq Age Sex Outcome Treatment
    1