BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15143521 · Received August 2, 2022

    Report

    Report Number
    9610877-2022-00534
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    July 21, 2022
    Report Date
    October 13, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    KGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK.

    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: WHEN THE PRODUCT WAS CONNECTED TO A HIGH-FREQUENCY SURGICAL DEVICE VIO300D (MANUFACTURED BY ELBE) AND AN ENERGIZATION TEST WAS CONDUCTED, IT WAS CONFIRMED THAT THERE WAS NO ENERGIZATION FAILURE AND THAT THE CUP WAS ENERGIZED. IT IS SPECULATED THAT THE CAUSE OF THE INABILITY TO CONDUCT ELECTRICITY IS THAT COAGULATED SUBSTANCES SUCH AS COAGULATED TISSUE AND BLOOD ADHERED TO THE CUP AND INTERFERED WITH CONDUCTION, RESULTING IN POOR CONDUCTION.

    Description of Event or Problem · 0

    H-S2518 (C021567) I TRIED TO STOP BLEEDING WITH THIS PRODUCT, BUT IT WAS REMOVED FROM THE ENDOSCOPE BECAUSE THE TIP CUP PART WAS NOT ENERGIZED. SINCE THE REPLACED HEMOSTAT-Y COULD BE USED WITHOUT ANY PROBLEMS, IT IS HIGHLY POSSIBLE THAT THERE WAS A PROBLEM WITH THIS PRODUCT. I WOULD LIKE TO REQUEST A REPORT OF THE OPINION FROM THE MANUFACTURER. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358948 PENTAX HOT HEMOSTASIS FORCEPS KGE HOYA CORPORATION PENTAX TOKYO OFFICE H-S2518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown