BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222467 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10356
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    March 25, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO THE U/D ANGLE WIRE WORN OUT. IN ADDITION, WE CONFIRMED THAT INSERTION FLEXIBLE TUBE(IFT) CRUSH, THE U/D AND R/L PULLEY WIRES WORN OUT; HOWEVER, THESE ARE NOT RELATED TO THE ALLEGED COMPLAINT. MODEL EG27-I10-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131902. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. U/D ANGLE WIRE RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119431 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG16-K10

    Patients

    Seq Age Sex Outcome Treatment
    1