BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB

    MDR report key: 8699770 · Received June 14, 2019

    Report

    Report Number
    1717344-2019-00758
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    January 17, 2019
    Report Date
    June 14, 2019
    Manufacturer
    NEW DEANTRONICS LTD
    Product Code
    GEI
    UDI-DI
    10884521750593
    PMA / PMN Number
    K182772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING EXCISION CERVICAL LEEP, THE DEVICE STOPPED WORKING DURING CRITICAL ACTIVATION PHASE WHEN CERVICAL CONE BIOPSY WAS PARTIALLY REMOVED FROM THE CERVIX, UNABLE TO ACTIVATE PENCIL AGAIN WHICH RESULTED IN EXCESSIVE AMOUNT OF 800 CC BLOOD LOSS. SUTURING WAS DONE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493771 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI NEW DEANTRONICS LTD SEP5000 1806065X 10884521750593

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention