BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 17115659 · Received June 13, 2023

    Report

    Report Number
    9610877-2023-55354
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    June 2, 2023
    Report Date
    June 13, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333211692
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE AIR TUBE CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE AIR TUBE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE OPERATION CHANNEL (PRIMARY) BUCKLED, THE WATER TUBE CLOGGED, THE LG WATER SUPPLY TUBES CLOGGED, THE LG AIR SUPPLY TUBES CLOGGED, THE BENDING RUBBER CUT, THE SEGMENT HARD TO MOVE, THE INSERTION FLEXIBLE TUBE TWISTED/BUCKLED UNDER AND THE ROOT BRACE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0630(AIR/WATER & JET WATER CHANNELS)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999896 PENTAX VIDEO GASTROSCOPE - I10 STANDARD FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10 04961333211692

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown