BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12764315 · Received November 7, 2021

    Report

    Report Number
    9610877-2021-01414
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 14, 2021
    Report Date
    February 16, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION G6: FOLLOW UP #1 H2:IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION H4:DEVICE MANUFACTURE DATE EVALUATION SUMMARY PENTAX MIYAGI FACTORY RECEIVED THIS SCOPE AND CONFIRMED THE DEFECT CONDITION. THEY ALSO IDENTIFIED THAT DRIVER BOARD WAS THE CAUSE OF DEFECT, NOT CCD. WE REPLACED A NEW SCOPE.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    THE SCOPE EG29-I10 A160956 IS THE DISTRIBUTOR DEMO. THE SCOPE WAS FOUND BLACKOUT AT THE DISTRIBUTOR PLACE AND CALLED PENTAX FSE. THIS SCOPE WASN'T USED ON THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655194 PENTAX VIDEO UPPER G.I.SCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown