BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12650745 · Received October 18, 2021

    Report

    Report Number
    9610877-2021-01072
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 18, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    D216954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO SCOPE EC-3890LI. IN THE EVENT REPORTED, IT WAS STATED THAT THERE WAS NO VIDEO IMAGE. THE ANOMALY WAS DISCOVERED IN THE PROCEDURE ROOM BEFORE USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. THE DEVICE WAS RETURNED TO PENTAX FOR FURTHER EVALUATION ON SERVICE ORDER (B)(4). THE DEVICE WAS INSPECTED WHERE THE USER NARRATIVE WAS CONFIRMED. THE INSPECTION FINDINGS ARE AS FOLLOWS: OPERATION CHANNEL TWISTED IN BENDING SECTION; PVE ELECTRICAL PIN CORRODED; CCD CIRCUIT BOARD CORROSION; AIR/ WATER SOCKET CYLINDER O-RING CHIPPED; SHIELD COVER CORRODED; IMAGE BLACKOUT; FAILED WET LEAK TEST; PVE ELECTRICAL CONNECTOR FRAME HAS SEVERE CORROSION; FAILED DRY LEAK TEST; CUSTOMER COMPLAINT CONFIRMED; BENDING RUBBER PINHOLE; UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE; UMBILICAL CABLE BUMP AT PVE SIDE; FLUID INVASION IN PVE CONNECTOR; #1 REMOTE CONTROL BUTTON NOT WORKING; #2 REMOTE CONTROL BUTTON NOT WORKING; #3 REMOTE CONTROL BUTTON NOT WORKING. THE DEVICE IS IN THE PROCESS OF BEING REPAIRED AND WILL BE RETURN TO THE USE UPON COMPLETION. PARTS TO BE REPLACED: O-RINGS AND SEALS; BENDING RUBBER; PCB FOR CCD DRIVE PB-FREE; ELECTRICAL CONNECTOR ASSY. A REVIEW OF THE SERVICE HISTORY INDICATES THE DEVICE WAS ROUTINELY SERVICED AT A PENTAX FACILITY. ON 11-OCT-2021, A DEVICE HISTORY RECORD (DHR) REVIEW FOR MODEL EC3890LI, SERIAL NUMBER (B)(4) WAS PERFORMED AND THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 23FEB2010 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. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548646 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3890LI

    Patients

    Seq Age Sex Outcome Treatment
    1