BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE FX

    MDR report key: 4937337 · Received July 23, 2015

    Report

    Report Number
    3006451981-2015-00166
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 1, 2015
    Manufacturer
    COVIDIEN LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF INITIAL REPORT : (B)(6) 2015. TO DATE THE UNIT HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT : (B)(6) 2015.

    Description of Event or Problem · 1

    NEW/ADDITIONAL INFO: IT WAS PREVIOUSLY REPORTED THAT TWO FORCEFX GENERATORS WERE USED DURING THIS PROCEDURE. ADDITIONAL INFO RECEIVED INDICATES THAT ONE OF THE UNITS WAS A FORCEFX UNIT AND THE OTHER UNIT WAS SPECIFICALLY A FORCEFXCS GENERATOR. THE SITE DOES NOT KNOW WHICH OF THE TWO UNITS WAS IN USE WHEN THE REPORTED INCIDENT OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A FORCEFX GENERATOR WAS IN USE DURING A ROUTINE POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AND HALO FEMORAL TRACTION APPLICATION PROCEDURE IN WHICH THE PATIENT RECEIVED NON-PAD SITE BURNS TO HER ANKLES. THE BURNS WERE DESCRIBED AS BILATERAL ON DISTAL AND MEDIAL ASPECTS OF THE ANKLES, WITH THE LEFT ANKLE BURN BEING FULL THICKNESS AND THE RIGHT ANKLE BURN BEING 1ST TO 2ND DEGREE. THE BURNS WERE THE SIZE OF A PENCIL ERASER HEAD, AND WERE LOCATED WHERE NON-COVIDIEN SPINAL MONITORING DISK ELECTRODES HAD BEEN PLACED DURING THE PROCEDURE. THE BURNS WERE DETECTED AT THE END OF THE PROCEDURE WHEN THE PATIENT WAS TURNED FROM PRONE TO SUPINE AND ONTO THE TRANSPORT BED. THE BURNS WERE TREATED BY CLEANSING AND APPLYING ANTIBIOTIC OINTMENT AND DRESSINGS. IT IS NOT KNOWN IF OR WHAT ADDITIONAL TREATMENT MAY HAVE BEEN REQUIRED. TWO FORCEFX GENERATORS WERE USED DURING THIS PROCEDURE (SEE REMARKS ON PAGE 3) AND IT IS UNKNOWN WHICH UNIT WAS IN USE AT THE TIME THE BURNS OCCURRED. THE GENERATOR WAS SET AT COAG 60/60. COVIDIEN PRE PADS HAD BEEN POSITIONED ON THE PATIENT¿S BILATERAL POSTERIOR THIGHS FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479290 FORCE FX ELECTROSURGICAL GENERATOR GEI COVIDIEN LLC FORCEFX

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other| R