BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12250859 · Received July 30, 2021

    Report

    Report Number
    9610877-2021-10241
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 30, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333224463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. MODEL KW-1818CS IS AVAILABLE IN THE USA WITH A 510K NUMBER K010740. EVALUATION SUMMARY: IT WAS CAUSED DUE TO A PHYSICAL IMPACT ON THE DEVICE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THERE WAS NO REPORT OF PATIENT HARM. WHEN THE OPERATION WAS CHECKED BY STERILIZATION BEFORE USE, THE CUP DID NOT OPEN. IT COULD NOT BE USED IN THE INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153289 PENTAX FORCEPS WINDOW REUSABLE 1.8DIA 180L ODG HOYA CORPORATION PENTAX TOKYO OFFICE KW1818CS G003630 04961333224463

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization