BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12307963 · Received August 11, 2021

    Report

    Report Number
    9610877-2021-00445
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Report Date
    August 11, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE 510(K) IS UNKNOWN AS THE MODEL IS UNKNOWN. (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. MDR 9610877-2021-00302 IS BEING SUBMITTED FOR THE PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1170K, SERIAL NUMBER (B)(4). THIS REPORT IS BEING SUBMITTED FOR THE PENTAX MEDICAL CLEANING BRUSH, UNKNOWN MODEL, UNKNOWN SERIAL (B)(4).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES OF A "BRUSH STUCK/BROKEN IN CHANNEL DURING REPROCESSING". THE CLEANING BRUSH, UNKNOWN MODEL AND LOT NUMBER, WERE USED WITH PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1170K, SERIAL NUMBER (B)(4). THE PENTAX MEDICAL SALES REP RESPONDED TO THE GOOD FAITH EFFORT REQUEST VIA EMAIL ON 12-JUL-2021 STATING THAT THE FACILITY USES PENTAX MEDICAL CLEANING BRUSHES. THE REPRESENTATIVE REPLIED AGAIN ON 28-JUL-2021 STATING THAT THE CLEANING BRUSH MODEL AND LOT NUMBER ARE UNKNOWN. THEY ALSO CONFIRMED THAT THE PRODUCT REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT AND THE FACILITY FOLLOWS OPERATION METHODS INSTRUCTIONS FOR USE (IFU). THE BRUSH WAS RETURNED WITH THE CUSTOMER OWNED ENDOSCOPE FOR EVALUATION ON 14-JUL-2021. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATIONAL CHANNEL" CONFIRMING THE CUSTOMER COMPLAINT HOWEVER SERVICE COULD NOT CONFIRM IT TO BE A PENTAX BRUSH. THE TECHNICIAN ALSO DOCUMENTED THE FOLLOWING ADDITIONAL FINDINGS: PASSED DRY LEAK TEST, PASSED WET LEAK TEST, # 1 REMOTE CONTROL BUTTON COVER CRACKED, SUCTION FUNCTION NOT PERFORMED UNIT COMPROMISED. THE ENDOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, BENDING RUBBER, DISTAL END ASSY WITH TUBES, REMOTE CONTROL BUTTON(1)PB_FREE, SEGMENT STEEL BRAID. CONDITION OF THE RETURNED CLEANING BRUSH REMOVED FROM THE ENDOSCOPE PREVENTED FURTHER TESTING OF THE BRUSH. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207088 PENTAX CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1