BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 20197561 · Received September 12, 2024

    Report

    Report Number
    9610877-2024-56844
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 12, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K# IS BLANK. 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 BIOPSY INLET PIECE LOOSE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE BIOPSY INLET PIECE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE BIOPSY INLET PIECE LEAK; HOWEVER, THIS DEFECT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THIS DEFECT OCCURRED NOT DURING PROCEDURE. BASED ON THE TECHNICAL REPORT ""HR-RPT-0620(CONTROL BODY)"" 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. BIOPSY INLET PIECE LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475576 PENTAX FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP CAL HOYA CORPORATION PENTAX TOKYO OFFICE FI-16RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown