BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13539835 · Received February 16, 2022

    Report

    Report Number
    9610877-2022-50718
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 26, 2022
    Report Date
    February 16, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FB-15V IS AVAILABLE IN THE USA WITH A 510K NUMBER K951199. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CFB FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CFB. IN ADDITION, WE CONFIRMED THAT THE CONTROL BODY FLUID DAMAGE, AND THE BENDING RUBBER STRETCHED; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FB-15V IS AVAILABLE IN THE USA WITH A 510K NUMBER K951199. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CFB FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CFB. IN ADDITION, WE CONFIRMED THAT THE CONTROL BODY FLUID DAMAGE, AND THE BENDING RUBBER STRETCHED; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT 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).

    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
    528741 PENTAX FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS EOQ HOYA CORPORATION PENTAX TOKYO OFFICE FB-15RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown