BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13006762 · Received December 14, 2021

    Report

    Report Number
    9610877-2021-01864
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 14, 2021
    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

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. THIS DEVICE IS SINGLE USE. SINCE THE PRODUCT OF THE SAME STANDARD COULD BE USED WITHOUT ANY PROBLEM, IT IS POSSIBLE THAT THE PRODUCT IS DEFECTIVE.

    Description of Event or Problem · 0

    IN ORDER TO STOP BLEEDING AT THE BLEEDING POINT, NO ELECTRICITY WAS APPLIED WHEN USING THIS PRODUCT (AMCO VIO100C BIPOLAR 30W). NO FEVER WAS EMITTED ANYWHERE. 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
    1897101 PENTAX HEMOSTASIS FORCEPS, WD2.6, LN1800, QTY 5 KGE HOYA CORPORATION PENTAX TOKYO OFFICE HS-D2618

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown