BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12764314 · Received November 7, 2021

    Report

    Report Number
    9610877-2021-01366
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    June 1, 2021
    Report Date
    November 7, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. EVALUATION SUMMARY PENTAX (B)(4) CONFIRMED THAT THERE IS A RIDGE IN THE INLET. A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EB15-S01, LOT NUMBER EB5A001 WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED. CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY.

    Description of Event or Problem · 0

    DURING A DEMO INABILITY TO PASS THE ACCESSORY "BLUE LASER" DIAMETER 0.8MM IN THE OPERATING CHANNEL OF 3.0MM OF THE ONE PULMO. INABILITY TO DO THE EXAMINATION WITH OUR SINGLE-USE BRONCHOSCOPE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655197 PENTAX ENDOSCOPE, FLEXIBLE GCQ HOYA CORPORATION PENTAX TOKYO OFFICE EB15-S01 EB5A001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown