BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12200853 · Received July 21, 2021

    Report

    Report Number
    9610877-2021-10463
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    March 9, 2021
    Report Date
    September 7, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PENTAX INTERNAL REVIEW IT WAS DISCOVERED ON AUGUST 21, 2021 THAT THE EVENT WAS NOT REPORTABLE BUT FILED UNDER MDR (9610877-2021-10463) WHICH WAS SUBMITTED ON JULY 21, 2021. THIS COMPLAINT IS NOT REPORTABLE TO U.S. FDA BECAUSE SHA-P5 LEAK TESTER, MANUFACTURED BY PENTAX, IS DISTRIBUTED BY PENTAX ONLY IN OUS COUNTRIES (OUTSIDE OF THE U.S.). PENTAX DOES NOT DISTRIBUTE A SIMILAR DEVICE MANUFACTURED BY PENTAX. PENTAX DISTRIBUTES ZUTRON LEAKAGE TESTERS IN THE U.S. MANUFACTURED BY ZUTRON MEDICAL (OEM). THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 0

    DURING PENTAX INTERNAL REVIEW IT WAS DISCOVERED ON AUGUST 21, 2021 THAT THE EVENT WAS NOT REPORTABLE BUT FILED UNDER MDR (9610877-2021-10463) WHICH WAS SUBMITTED ON JULY 21, 2021. THIS COMPLAINT IS NOT REPORTABLE TO U.S. FDA BECAUSE SHA-P5 LEAK TESTER, MANUFACTURED BY PENTAX, IS DISTRIBUTED BY PENTAX ONLY IN OUS COUNTRIES (OUTSIDE OF THE U.S.). PENTAX DOES NOT DISTRIBUTE A SIMILAR DEVICE MANUFACTURED BY PENTAX. PENTAX DISTRIBUTES ZUTRON LEAKAGE TESTERS IN THE U.S. MANUFACTURED BY ZUTRON MEDICAL (OEM). THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO A MALFUCTION ON THE DEVICE. IT WAS NON-REPAIR ITEM SO THAT IT WAS REPLACED WITH NEW ONE. 510K IS BLANK. THIS DEVICE IS EXEMPT FROM 510K. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. LEAK TESTER DOES NOT HOLD THE PRESSURE. BALLOON VALVE DEFECT. NO DAMAGE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098655 PENTAX LEAKAGE TESTER FCY HOYA CORPORATION PENTAX TOKYO OFFICE SHA-P5

    Patients

    Seq Age Sex Outcome Treatment
    1