BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANCOAT LAPAROSCOPIC WIRE L HO

    MDR report key: 10086681 · Received May 22, 2020

    Report

    Report Number
    MW5094651
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 20, 2020
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    UDI-DI
    10884521550803
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING SURGERY LAPAROSCOPICALLY WITH A BOVIE AND L HOOK ELECTRODE. THE L-HOOK ELECTRODE SPARKED AND CAUSED A SMALL BURN UNDER THE TROCAR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548029 CLEANCOAT LAPAROSCOPIC WIRE L HO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN NR10734 REV A 1904170X 10884521550803

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR