BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12293420 · Received August 9, 2021

    Report

    Report Number
    9610877-2021-00302
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Report Date
    December 7, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    UDI-DI
    04961333232154
    PMA / PMN Number
    K131028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE CAUSE IS THOUGHT TO BE THAT THE BRUSH USED BY THE USER, DURING CLEANING WAS BROKEN AND REMAINED IN THE PIPE. PENTAX HAS ADDED A METHOD FOR ALERTING AND DETECTING IN IFU IN THE EVENT, AND ALSO IMPLEMENTED FIELD ACTION. THE EVENT WAS NOT A CLOGGED FOREIGN OBJECT THAT WAS UNKNOWINGLY USED ON THE NEXT PATIENT, BUT WAS SUCCESSFULLY DETECTED. AND A COMPLAINT WAS REPORTED. CORRECTION INFORMATION: H6: CODING CHANGED, BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES OF A "BRUSH STUCK/BROKEN IN CHANNEL DURING REPROCESSING" INVOLVING 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 28-JUL-2021, STATING THAT THE CLEANING BRUSH WAS A PENTAX MEDICAL CLEANING BRUSH, UNKNOWN MODEL AND LOT NUMBER. 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 CUSTOMER OWNED ENDOSCOPE WAS RETURNED 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 AND DOCUMENTING 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 DEVICE 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. MODEL EB-1170K, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. 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 WAS REPAIRED AND APPROVED BY FINAL QC ON 05-AUG-2021 AND WAS DELIVERED TO THE CUSTOMER UNDER DELIVERY ORDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190811 PENTAX VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB-1170K 04961333232154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown