BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12488410 · Received September 17, 2021

    Report

    Report Number
    9610877-2021-01009
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Report Date
    September 17, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. MDR 9610877-2021-00077 WAS SUBMITTED FOR THE PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1170K, SERIAL NUMBER (B)(4). MDR 9610877-2021-01009 IS BEING SUBMITTED FOR THE PENTAX MEDICAL CLEANING BRUSH, MODEL CS4010A, UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 25-MAR-2021 OF A "BRUSH STUCK/BROKEN IN CHANNEL" INVOLVING THE PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1170K, SERIAL NUMBER (B)(4). THE USER FACILITY RESPONDED TO THE GOOD FAITH EFFORT REQUEST VIA EMAIL ON 30-MAR-2021, STATING THAT THE CLEANING BRUSH WAS AN OEM CLEANING BRUSH, MODEL CS4010A, UNKNOWN LOT NUMBER, SIZE 1.8MM-3.2MM CLEANING BRUSH. THE CUSTOMER OWNED BRONCHOSCOPE WAS RETURNED FOR EVALUATION ON 31-MAR-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 AND BROKEN ACCESSORY BLOCKING BIOPSY T-PIECE" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 01-APR-2021: UMBILICAL CABLE BUCKLE AT CONTROL BODY SIDE, UMBILICAL CABLE BUCKLE AT UMBILICAL CONNECTOR SIDE, UP/ DOWN BRAKE LEVER CRACKED, UP/ DOWN CONTROL KNOB/ LEVER CRACKED, FAILED DRY LEAK TEST, FAILED WET LEAK TEST, # 4 REMOTE CONTROL BUTTON COVER CRACKED, BENDING RUBBER LEAK AT MIDDLE SECTION, LEAK AT # 1 REMOTE CONTROL BUTTON COVER, BENDING RUBBER CUT, INSERTION TUBE BUCKLES AT END OF ROOT BRACE, INSERTION TUBE BUCKLES AT STAGE 3. THE ENDOSCOPE DAMAGE NOTED COULD HAVE CONTRIBUTED TO THE CLEANING BRUSH BECOMING STUCK DURING REPROCESSING. NO ADDITIONAL TESTING WAS PERFORMED ON THE CLEANING BRUSH. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: DISTAL END ASSY WITH TUBES, DISTAL ATTACHING PIN, SEGMENT STEEL BRAID, INSERTION/S-NIPPLE ATTACHING SCREW, O-RING(1.25X3.5), SUCTION CONNECTION TUBE, O-RING(1.2X3.5), LIGHT GUIDE CABLE, FRICTION LEVER ASSY, ANGLE LEVER ASSY, R.C. BUTTON (4) PB-FREE, BIOPSY INLET T-PIECE. 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. MDR 9610877-2021-00077 WAS SUBMITTED FOR THE PENTAX MEDICAL VIDEO BRONCHOSCOPE, MODEL EB-1170K, SERIAL NUMBER (B)(4). MDR 9610877-2021-01009 IS BEING SUBMITTED FOR THE PENTAX MEDICAL CLEANING BRUSH, MODEL CS4010A, UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384357 PENTAX SINGLE USE CHANNEL CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS4010A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1