BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 10795632 · Received November 5, 2020

    Report

    Report Number
    9610877-2020-00188
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 16, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333135899
    PMA / PMN Number
    K182004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS IS DUE TO THE FACT THAT WHEN THE NEEDLE IS USED WITH A BENT OR OTHERWISE BENT NEEDLE, THE NEEDLE DOES NOT RIDE ON THE ELEVATOR SECTION AND FORCEPS RAISING IS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 06-OCT-2020 THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE "22 GAUGE NEEDLE DID NOT EXIT THE ENDOSCOPE ON THE ELEVATOR. IT EXITED THE SCOPE ON THE SIDE OF THE ELEVATOR WERE IT WAS NOT IN VIEW OF THE CAMERA OR ULTRASOUND. NUMEROUS ATTEMPTS WERE MADE UNTIL THEY FIGURED OUT WHAT WAS OCCURRING. ", INVOLVING PENTAX MEDICAL VIDEO ULTRASOUND GASTROSCOPE, MODEL EG-3870UTK, SERIAL NUMBER (B)(4). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN A PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER OWNED VIDEO ULTRASOUND GASTROSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 14-OCT-2020. THE GASTROSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE SERVICE TECHNICIAN DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 21-OCT-2020. ELEVATOR BODY FNA NEEDLE IS COMING OUT NOT ALIGNED, ELEVATOR KNOB PLAY, PASSED WET LEAK TEST, SUCTION TUBE RESISTANCE, PASSED DRY LEAK TEST, UMBILICAL CABLE BUMP AT CONTROL BODY SIDE, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY, ULTRASOUND IMAGE HAS BROKEN CHANNEL, EUS CONNECTOR CABLE SHORT BUMP AT CONTROL BODY ROOT BRACE. THE GASTROSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, SUCTION CHANNEL LG. ON 23-OCT-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EG-3870UTK, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER IVAI-20-100092, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 23-APR-2014 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 24-APR-2014. MODEL EG-3870UTK, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2014. THE VIDEO ULTRASOUND GASTROSCOPE WAS DELIVERED TO THE CUSTOMER ON (B)(6) 2020 UNDER DELIVERY ORDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256315 PENTAX LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG-3870UTK 04961333135899

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown