BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19789977 · Received July 22, 2024

    Report

    Report Number
    9610877-2024-55573
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 22, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US, SO THAT 510K# IS BLANK. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED, THAT THE IMAGE SHADOW IN IMAGE. BASED ON THE RESULT, WE CONCLUDED, THAT IT WAS CAUSED, DUE TO THE EXCESSIVE FORCE APPLIED ON THE IMAGE. IN ADDITION, OUR TECHNICIAN CONFIRMED, THAT THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE INSERTION FLEXIBLE TUBE CRUSHED, THE SEGMENT CRUSHED, THE BENDING RUBBER LEAK, THE BODY COVER GRIP LOOSE, THE OPERATION CHANNEL (PRIMARY) RESISTANCE, THE ANGULATION DOWN ANGULATION DECREASE AND THE ANGULATION UP ANGULATION DECREASE. 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-0586 (IMAGE FAILURE)" 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. FIBER IMAGE FAILURE (SHADOW IN IMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119156 PENTAX FIBEROPTICINTUBATIONSCOPE 1.4C 3.4TP ROP CAL HOYA CORPORATION PENTAX TOKYO OFFICE FI-10RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown