BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMA JET

    MDR report key: 645123 · Received October 31, 2005

    Report

    Report Number
    645123
    Event Type
    Malfunction
    Date Received
    October 31, 2005
    Date of Event
    October 26, 2005
    Report Date
    October 27, 2005
    Manufacturer
    PLASMA SURGICAL INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2005 DURING PANNICULECTOMY PLASMA JET ACCIDENTALLY AND UNKNOWINGLY WAS ENGAGED BY SURGEON CAUSING HOLE IN BOVIE HOLSTER AND A HOLE IN THE DRAPES. PLASMA JET DID NOT ALARM WHEN ACCIDENTALLY ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMA JET COAGULATOR GEI PLASMA SURGICAL INC PC 102100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other