BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOTOM 804E

    MDR report key: 334317 · Received May 22, 2001

    Report

    Report Number
    1220063-2001-00020
    Event Type
    Injury
    Date Received
    May 22, 2001
    Date of Event
    January 24, 2001
    Report Date
    May 17, 2001
    Manufacturer
    SIEMENS MEDICAL SYSTEMS INC. EM-P
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INCIDENT DESCRIPTION WAS FORWARDED TO SIEMENS MEDICAL SYSTEMS INC EM PCS (VIA SIEMENS AG, IN GERMANY) BY AN ATTORNEY FOR A PT WHO ALLEGEDLY RECEIVED INJURIES FROM AN ESU PROCEDURE PERFORMED AT HOSPITAL OVERSEAS. (USER FACILITY WHICH OWNS THE DEVICE) HAS NOT CONTACTED SIEMENS REGARDING THIS INCIDENT. THE INCIDENT IS DESCRIBED AS FOLLOWS: PT SUFFERED SERIOUS BURNS DURING AN OPERATION PROCEDURE, USING AN ELECTROCAUTERIZER DEVICE (RADIOTOM 804E).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23849 RADIOTOM 804E ELECTROSURGICAL INSTRUMENT GEI SIEMENS MEDICAL SYSTEMS INC. EM-P 8049264E2262 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other