BEUDAMED
    FDA Adverse Event Death Summary report: N

    (D) ELECTROSURGICAL GENERATOR X1

    MDR report key: 5001932 · Received August 13, 2015

    Report

    Report Number
    1717344-2015-00551
    Event Type
    Death
    Date Received
    August 13, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 5, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED FORCE FX-8C GENERATOR WAS RECEIVED AND EVALUATED BY COVIDIEN. NOTHING WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE UNIT TESTED SATISFACTORILY AND WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTEDLY, AN ALARM SOUNDED AT SOME POINT DURING THE PROCEDURE. THE ALCOHOL-BASED DISINFECTANT USED WAS IDENTIFIED AS SOFTASEPT N - COLORED, LOT# 15213M14, EXP. 4/20. THE HOSPITAL CANNOT PROVIDE MORE INFORMATION BECAUSE OF (B)(6) LAW REGARDING PERSONAL DATA PROTECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DIED DURING AN ACUTE CARDIOSURGERY. THE FORCEFX-8C ELECTROSURGICAL GENERATOR HAD BEEN IN USE DURING THE PROCEDURE. THE SURGEON HAD APPLIED AN ALCOHOL-BASED DISINFECTANT SOLUTION TO THE PATIENT'S BODY JUST PRIOR TO USING THE ELECTROSURGICAL GENERATOR AND ACCESSORIES. REPORTEDLY, THEY DID NOT WAIT FOR THE DISINFECTANT TO DRY. THE WIMPLES AND DRAPES ON THE PATIENT'S BODY COMBUSTED. THE BURNING WIMPLES AND DRAPES WERE IMMEDIATELY PULLED DOWN FROM THE PATIENT'S BODY, AND THE GENERATOR WAS SHUT DOWN AND REMOVED FROM THE SURGICAL FIELD. THE PATIENT WAS NOT BURNED. THE PATIENT DIED DURING THE CARDIOSURGERY DUE TO A HEART ATTACK. ADDITIONAL QUESTIONS HAVE BEEN ASKED REGARDING THIS INCIDENT.

    Description of Event or Problem · 1

    NEW/ADDITIONAL INFO: REPORTEDLY, AN ALARM SOUNDED AT SOME POINT DURING THE PROCEDURE. THE ALCOHOL-BASED DISINFECTANT USED WAS IDENTIFIED AS SOFTASEPT N - COLORED, LOT# 15213M14, EXP. 4/20. THE HOSPITAL CANNOT PROVIDE MORE INFORMATION BECAUSE OF (B)(6) LAW REGARDING PERSONAL DATA PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533546 (D) ELECTROSURGICAL GENERATOR X1 ELECTROSURGICAL GENERATR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death