BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19170043 · Received April 24, 2024

    Report

    Report Number
    9610877-2024-53041
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    April 15, 2024
    Report Date
    April 24, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    PMA / PMN Number
    K951196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CFB (COHERENT FIBER BUNDLE) FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CFB (COHERENT FIBER BUNDLE). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE CONTROL BODY FLUID DAMAGE, THE U/D KNOB BROKEN, THE INSERTION FLEXIBLE TUBE PERFORATED, THE INSERTION FLEXIBLE TUBE BUCKLED, THE LIGHT GUIDE CABLE FOR PRONG BUCKLED, THE SEGMENT CRUSHED, AND THE ANGLE WIRE HARD TO MOVE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. 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 UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070418 PENTAX FIBER NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE FNL-7RP3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown