BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 20875639 · Received December 9, 2024

    Report

    Report Number
    9610877-2024-58932
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    December 3, 2024
    Report Date
    December 9, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NOT DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT ARE LISTED IN USA. 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 LCB DISTAL COVER GLASS BROKEN, THE INSERTION FLEXIBLE TUBE COMPRESSED (SHORT IN LENGTH), THE ANGLE WIRE PLAY, THE WATER JET TUBE CLOGGED, THE LG WATER JET SUPPLY TUBES CLOGGED, THE NOZZLE GLUING MISSING, THE LCB (LIGHT CARRYING BUNDLE) CRUSHED, THE AIR AND THE WATER NOZZLES DEFORMED, THE REMOTE CONTROL BUTTONS CUT, THE OBJECTIVE LENS SCRATCHED, THE LCB DISTAL COVER GLASS SCRATCHED, THE WATER JET TUBE DIRTY, THE AIR AND THE WATER TUBES DIRTY, THE LG WATER JET SUPPLY TUBES DIRTY, THE REMOTE CONTROL BUTTONS DISINFECTIONS DAMAGE, THE BENDING RUBBER WORN OUT, THE DISTAL BODY WORN OUT, THE SEGMENT WORN OUT, THE ROOT BRACE RUBBER (INSERTION FLEXIBLE TUBE) DISCOLORED, AND THE ROOT BRACE RUBBER (LG CONTROL BODY) DISCOLORED; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THIS DEFECT OCCURRED NOT DURING PROCEDURE. 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
    106179 PENTAX VIDEO GASTROSCOPE - I10 STANDARD FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown