BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORCE FX

    MDR report key: 3692505 · Received March 11, 2014

    Report

    Report Number
    1717344-2014-00154
    Event Type
    Death
    Date Received
    March 11, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THAT THE INCIDENT UNIT WOULD NOT BE RETURNING FOR EVAL. IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PLACEMENT OF PERMANENT PACEMAKER AFTER THE PHYSICIAN INJECTED ABOUT 20CC OF LIDOCAINE COCKTAIL HE PICKED UP THE ESU PENCIL TO CONTROL SOME BLEEDERS. UPON ACTIVATION OF THE PENCIL THERE WAS A SPARK FLASH FROM THE PENCIL'S TIP TOWARD THE STERILE FIELD AND UP THE PT'S CHIN AREA. WITHIN A SECOND A FLASH FIRE OCCURRED THROUGH THE SURGICAL TOWELS AND THE 3M IOBAN 2 SURGICAL DRAPE. THEN FLAMES SHOT OUT OF THE MASK'S TUBING AND BURST THE FACEMASK BAG. FIRE WAS NOTED AROUND THE PT'S FACEMASK AND HAIR. THE BURNING SURGICAL DRAPE WAS REMOVED AND STOMPED OUT WHILE THE NURSE TURNED THE OXYGEN SOURCE OFF. IT TOOK 10-15 SECONDS TO EXTINGUISH THE FIRE. FIRE RESULTED IN 1ST AND 2ND DEGREES THERMAL BURNS TO THE PT'S FACE AND NECK. PT WAS INTUBATED TO PROTECT THE AIRWAY AND TRANSFERRED TO A BURN CENTER. THE PT EXPIRED ON (B)(6) 2013 FROM CONGESTIVE HEART FAILURE COMPLICATED BY THERMAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146373 FORCE FX ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 3M IOBAN ANTIMICROBIAL INCISE DRAPE, E25B| COVIDIEN DISPOSABLE HANDSWITCH PENCIL,| CONMED ELECTRODE, #410-2000, LOT# 310304| OXYGEN MASK, REF# 1059| W/HOLDER ID# E2515H, LOT# UNK| CAREFUSION, CHOLORAPREP WITH TINT, LOT# 66846| CAREFUSION, CHOLORAPREP WITH TINT, LOT# 66827| TELEFLEX MEDICAL, HUDSON RCI NON-REBREATHER,