BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222497 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10242
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333224463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL KW-1818CS IS AVAILABLE IN THE USA WITH 510K NUMBER K010740. EVALUATION SUMMARY: IT WAS CAUSED DUE TO AN EXCESSIVE FORCE APPLIED ON THE CUP DURING USE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. WHEN I CHECKED THE OPERATION WITH STERILIZATION BEFORE USE, THE CUP DID NOT OPEN. CANNOT BE USED FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119493 PENTAX FORCEPS WINDOW REUSABLE 1.8DIA 180L ODG HOYA CORPORATION PENTAX TOKYO OFFICE KW1818CS 04961333224463

    Patients

    Seq Age Sex Outcome Treatment
    1