BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (D) FORCE EZ INTERNATIONAL X1

    MDR report key: 3981493 · Received July 25, 2014

    Report

    Report Number
    1717344-2014-00633
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT UNIT 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 OF IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE COAGULATION OUTPUT SETTING SWITCHED TO THE HIGHEST POWER OUTPUT WITHOUT ANY ADJUSTMENT BY THE STAFF. A SPARK OCCURRED WHICH CAUSED A BURN TO THE PATIENT'S SURGICAL SITE. THE SURGEON EXCISED THE DAMAGED TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436977 (D) FORCE EZ INTERNATIONAL X1 ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention EXTENDED COATED BLADE: ID-E14506, LOT-UNK| REUSABLE PENCIL W/15FT CORD: ID-E2100, LOT-UNK