BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 3802884 · Received April 30, 2014

    Report

    Report Number
    1717344-2014-00307
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 2, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNIT WAS RETURNED AND NOTHING WAS FOUND THAT WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION OF A PATIENT BURN. THE GENERATOR WAS TESTED AND WAS FOUND TO MEET AL THE MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A BOARI FLAP A MEMBER OF THE STAFF STEPPED ON THE FOOTPEDAL WHICH ACTIVATED THE UNIT WHILE THE PENCIL WAS ON THE PATIENTS' RIGHT UPPER ABDOMEN CAUSING A BURN. THE PENCIL WAS DISCARDED BY THE SITE. THE BURN WAS EXCISED AND SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258138 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SKINTACT PENCIL: (REF NO HCP-01), L/N (B)(4),| RP2 MONOPOLAR PEDAL LOT #: 19372