BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12457501 · Received September 10, 2021

    Report

    Report Number
    9610877-2021-00630
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 10, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333186822
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. PENTAX MODEL EC34-I10L IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. PENTAX SAME MODEL EC34-I10L-US IS DISTRIBUTED IN THE USA WITH 510K K131855.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE USA STATING, " NO VIDEO IMAGE" INVOLVING PENTAX MODEL EC34-I10L/SERIAL (B)(4). THE EVENT WAS REPORTED TO HAVE OCCURRED DURING REPROCESSING. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. PENTAX MADE 3 GOOD FAITH EFFORT ATTEMPTS TO CONFIRM INITIAL DETAILS AND COLLECT ADDITIONAL INFORMATION FROM THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FACILITY STATING THE EVENT OCCURRED AT THE START OF THE PROCEDURE WHEN THE DEVICE WAS IN THE PATIENT. THE DEVICE WAS REMOVED, AND A NEW DEVICE WAS USED TO PROCEED WITH THE PROCEDURE. THE FACILITY CONTACT ALSO STATED NO MEDICAL INTERVENTION WAS REQUIRED AND NO ADVERSE EVENTS OCCURRED TO THE PATIENT. THE DEVICE WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION. PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED: FLUID INVASION TO INSERTION TUBE, FLUID INVASION IN SEGMENT SECTION, FLUID INVASION IN CONTROL BODY, INSERTION TUBE BUCKLES AT END OF ROOT BRACE, CONTROL BODY GRIP SCRATCHED, PVE ELECTRICAL PIN CORRODED, IMAGE BLACKOUT, FAILED DRY LEAK TEST, SUCTION TUBE RESISTANCE, ENDOSCOPE FAILED ELECTRICAL SAFETY TEST - PLCT, FAILED WET LEAK TEST, LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) INLET SIDE, BENDING RUBBER SEVERE DISCOLORATION, FLUID INVASION IN PVE CONNECTOR, OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY, PVE CONNECTOR HOUSING SCRATCHED, SUCTION FUNCTION NOT PERFORMED UNIT COMPROMISED, UMBILICAL CABLE SINGLE HAS SEVERE SCRATCH, FLUID INVASION IN UMBILICAL LIGHT GUIDE CABLE, FLUID DAMAGE TO LIGHT CARRYING BUNDLE, OPERATION CHANNEL- PRIMARY, KINKED AT END OF INSERTION ROOT, PVE ELECTRICAL CONNECTOR FRAME MILD CORROSION, CONTROL BODY MILD CORROSION INSIDE. REPAIRS ARE BEING PERFORMED ON THE DEVICE WHICH WILL INCLUDE REPLACEMENT OF THE FOLLOWING COMPONENTS: RL PULLEY ASSY, UD PULLEY ASSY, O-RINGS AND SEALS, SEGMENT STAYCOIL ASSY PB-FREE, STAYCOIL COLLAR, INSERTION FLEXIBLE TUBE, DISTAL END ASSY WITH TUBES, DISTAL ATTACHING PLATE, SEGMENT ASSY ATTACHING SCREW, ADJUSTING COLLAR, LIGHT GUIDE FIBER BUNDLE (LCB), PCB FOR CCD DRIVE PB-FREE, ELECTRICAL CONNECTOR ASSY, BENDING RUBBER, SHIELD PIPE FOR CCD, SIGNAL WIRE FOR CCD PR-FREE, CONDUCTIVE PLATE, SWITCH W/BUTTON RETAINING NUT2, SWITCH W/BUTTON RETAINING NUT3, SWITCH W/BUTTON RETAINING NUT4, REMOTE CONTROL BUTTON(1), SUCTION CHANNEL LG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354465 PENTAX VIDEO COLONOSCOPE - I10 SLIM FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC34-I10L 04961333186822

    Patients

    Seq Age Sex Outcome Treatment
    1