BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 3883881 · Received June 11, 2014

    Report

    Report Number
    1717344-2014-00498
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    October 1, 2013
    Report Date
    June 4, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN APPENDECTOMY, FOLLOWING USE OF AN ELECTROSURGICAL HAND PIECE, A FLAME WAS NOTED ON PT'S RIGHT SIDE. THE FLAME WAS EXTINGUISHED USING OPERATING ROOM TOWELS AND WATER. ALCOHOL DISINFECTANT HAD BEEN USED AS THE SURGICAL PREP DUE TO PT'S IODINE TINCTURE ALLERGY. PT SUSTAINED BURNS ON RIGHT SIDE, RIGHT THIGH AND INNER LEFT THIGH. BURNS WERE CLASSIFIED AS 2ND AND 3RD DEGREE. TREATMENT OF PT'S BURNS UNK AT THIS TIME. THERE WAS AN EXTENSION OF HOSP STAY BY 20 DAYS. THE SURGEON ALSO SUSTAINED MINOR BURNS ON HIS HANDS DUE TO HIS GLOVES CATCHING ON FIRE WHILE ATTEMPTING TO EXTINGUISH THE FLAME. CLASSIFICATION OF AND TREATMENT OF SURGEON'S BURNS UNK AT THIS TIME. ADDITIONAL QUESTIONS REGARDING THIS INCIDENT HAVE BEEN EXTENDED TO SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344756 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O COVIDIEN POLYHESIVE II RET ELEC 15' CORD,| FIAB F42477| E7507DB, LOT # UNK