BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11580562 · Received March 29, 2021

    Report

    Report Number
    9610877-2021-00069
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Report Date
    February 26, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333129492
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON (B)(6) 2021 THAT OCCURRED DURING REPROCESSING IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE CLEANING BRUSH BECAME STUCK AT THE DISTAL END DURING CLEANING, INVOLVING THE PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG-2990I, SERIAL NUMBER (B)(4) . NO PATIENT INVOLVEMENT WAS REPORTED. THE CUSTOMER RESPONDED TO A GOOD FAITH EFFORT(GFE) VIA EMAIL ON 03-MAR-2021, AND STATED THAT THE CLEANING BRUSH WAS A MEDIVATORS, PULL THRU 2.8-5.0MM ID BRUSH. IT IS MADE FOR LUMEN CHANNELS 2.8-5.0 MM ID. REF NUMBER IS 100405. THE CUSTOMER OWNED ENDOSCOPE WAS RETURNED FOR EVALUATION ON 09-MAR-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) ON 09-FEB-2021, AND THE TECHNICIAN CONFIRMED. THE TECHNICIAN ALSO DOCUMENTED THE FOLLOWING FAILURE CODES ON (B)(6) 2021: PASSED DRY LEAK TEST, PASSED WET LEAK TEST, CONTROL BODY MILD CORROSION INSIDE, FLUID INVASION IN CONTROL BODY. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, OPERATION CHANNEL, ADJUSTING COLLAR, BENDING RUBBER, ANGLE WIRE, RL PULLEY ASSY, UD PULLEY ASSY, O-RING (1.8X19.8), UD KNOB, AIR/WATER SUPPLY TUBE LG, JET SUPPLY TUBE LG, SUCTION CHANNEL LG, BASE PLATE, UD LOCK LEVER. PENTAX MEDICAL MODEL EG-2990I, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2008. 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. THE ENDOSCOPE IS AWAITING REPAIR AND APPROVED BY FINAL QC AS OF 28-MAR-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479862 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990I 04961333129492

    Patients

    Seq Age Sex Outcome Treatment
    1