BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13049131 · Received December 20, 2021

    Report

    Report Number
    9610877-2021-01899
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    March 31, 2021
    Report Date
    December 20, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. WE COULDN'T INVESTIGATE BECAUSE THE DEVICE WAS NOT RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    THE USER FOUND THAT THE SCOPE WAS WATERLOGGED ,AND THE IMAGE HAD FILIFORM DEFECT, THEN CONTACTED THE DEVICE DEPARTMENT. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947140 PENTAX CHOLED-NEPHRO SCOPE GCQ HOYA CORPORATION PENTAX TOKYO OFFICE FCN-15X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown