BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8723087 · Received June 21, 2019

    Report

    Report Number
    9610877-2019-00342
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    May 24, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOYA CORPORATION PENTAX TOKYO OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX TOKYO OFFICE (EXEMPTION NUMBER (B)(4)). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2019 STATING "CONTROL BODY BROKEN-PEELING AT 30CM" INVOLVING VIDEO COLONOSCOPE MODEL EC-3890TLI/SERIAL (B)(4) THROUGH THE PENTAX MEDICAL SERVICE DEPARTMENT. NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. THE CUSTOMER OWNED VIDEO COLONOSCOPE WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION. THE PENTAX ENDOSCOPE TECHNICIAN CONFIRMED, ON 24/MAY/2019, AN ACCESSORY STUCK INSIDE THE FORWARD WATER JET SOCKET. OTHER INSPECTIONAL FINDINGS INCLUDED: INSERTION TUBE COATING PEELING OFF AT STAGE 1, INSERTION TUBE COATING PEELING OFF AT STAGE 2, DISTAL BODY CHIP AT CHANNEL OPENING AT THINNEST PART, PASSED WET LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, PASSED DRY LEAK TEST, F/W JET FUNCTION TESTING NOT PERFORMED UNIT COMPROMISED, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY, PRIMARY OPERATION CHANNEL RESISTANCE, RESIDUE ON BENDING RUBBER. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO THE CUSTOMER VIA EMAIL AND PHONE TO GATHER ADDITIONAL INFORMATION FOR THE EVENT. NO INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER. BASED ON THE CUSTOMER COMPLAINT, IT IS REASONABLE TO CONCLUDE THAT THE USER WAS NOT AWARE OF THE ACCESSORY STUCK INSIDE THE FORWARD WATER JET SOCKET. IF ADDITIONAL INFORMATION IS RECEIVED, THE MDR WILL BE SUPPLEMENTED. 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. REPAIRS WERE PERFORMED ON THE VIDEO COLONOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: INSERTION FLEXIBLE TUBE, DISTAL END ASSY WITH TUBES, DISTAL ATTACHING PLATE, SEGMENT ASY ATTACHING SCREW, RL AND UD PULLEY ASSY, ADJUSTING COLLAR, ANGLE WIRE, REMOTE CONTROL BUTTON, SUCTION CHANNEL LG, AIR/WATER SUPPLY TUBE LG, JET SUPPLY TUBE LG, O-RINGS AND SEALS, BENDING RUBBER. THE VIDEO COLONOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 18/JUN/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515035 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3490TLI

    Patients

    Seq Age Sex Outcome Treatment
    1