BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANCOAT

    MDR report key: 10246842 · Received July 8, 2020

    Report

    Report Number
    1717344-2020-00708
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    May 13, 2020
    Report Date
    July 8, 2020
    Manufacturer
    NEW DEANTRONICS LTD
    Product Code
    GEI
    UDI-DI
    10884521550803
    PMA / PMN Number
    K153265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE DEVICE SPARKED AND CAUSED A SMALL BURN UNDER THE TROCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708765 CLEANCOAT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI NEW DEANTRONICS LTD E3773-36C 1904170X 10884521550803

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR