BEUDAMED
    FDA Adverse Event Summary report: N

    SYSTEM 2450 ESU (ELECTROSURGICAL UNIT)

    MDR report key: 2875830 · Received December 17, 2012

    Report

    Report Number
    1720159-2012-00118
    Date Received
    December 17, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K 052009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION, THE SYSTEM 2450, IS AN ELECTROSURGICAL UNIT (ESU) THAT PROVIDES BOTH MONOPOLAR AND BIPOLAR MODES FOR USE IN PROCEDURES REQUIRING ELECTROSURGICAL CUTTING OR COAGULATION. THE ESU WAS RETURNED TO CONMED CORPORATION FOR EVALUATION. THE RETURNED UNIT POWERS UP NORMALLY WITH NO ERRORS. ALL OUTPUTS ARE WITHIN SPECIFICATIONS. ALL HAND AND FOOT PORTS ARE WORKING PROPERLY. ARM (AUTOMATIC RETURN MONITOR) CIRCUIT IS PERFORMING AS INTENDED. LFC, LAST FAULT CODE, WHICH STORES UP TO FIFTY (50) ERROR CODES WAS CLEAR. CONMED COULD NOT DUPLICATE ANY PROBLEM WITH THE RETURNED ESU. NO PROBLEM WAS FOUND WITH THE RETURNED ESU. IT WAS NOTED IN THE INCIDENT DESCRIPTION BY THE END-USER THAT THE "SPARK" THAT WAS GENERATED CAUSED A SINGE MARK ON THE PATIENT'S CHEEK. IT WAS ALSO REPORTED THAT THE PATIENT WAS ON OXYGEN SUPPLIED BY NASAL CANNULA. IN THE SYSTEM 2450, ELECTROSURGICAL GENERATOR, OPERATOR MANUAL, SECTION 1.1.2 CAUTIONS FOR PATIENT PREPARATION, IT STATES: SECTION 1.1.2, CAUTIONS FOR PATIENT PREPARATION: "ELECTROSURGERY SHOULD NEVER BE PERFORMED IN THE PRESENCE OF FLAMMABLE ANESTHETICS, FLAMMABLE PREP SOLUTIONS OR DRAPES, OXIDIZING GASES SUCH AS NITROUS OXIDE (N2O) OR IN OXYGEN-RICH ENVIRONMENTS. THE RISK OF IGNITING FLAMMABLE GASES OR OTHER MATERIALS IS INHERENT IN ELECTROSURGERY AND CANNOT BE ELIMINATED BY DEVICE DESIGN. PRECAUTIONS MUST BE TAKEN TO RESTRICT FLAMMABLE MATERIALS ANS SUBSTANCES FROM THE ELECTROSURGICAL SITE. THEY MAY BE PRESENT IN THE FORM OF AN ANESTHETIC, LIFE SUPPORT, SKIN PREPARATION AGENT, PRODUCED BY NATURAL PROCESSES WITHIN BODY CAVITIES OR ORIGINATE IN SURGICAL DRAPES, TRACHEAL TUBES, OR OTHER MATERIALS." THIS INCIDENT, A SPARK THAT CAUSED A SINGE MARK ON THE PATIENT'S CHEEK OCCURRED IN AN OXYGEN-RICH ENVIRONMENT FOR THE PATIENT WAS BEING SUPPLIED LIFE-SUPPORTING OXYGEN VIA NASAL CANNULA. THIS CREATED AN OXYGEN RICH ENVIRONMENT SURROUNDING THE NARES OF THE PATIENT. THE CHEEK OF THE PATIENT IS IN VERY CLOSE PROXIMITY TO THEIR NARES WHERE THE OXYGEN WAS BEING DELIVERED AND IT IS THEREFORE SAFE TO PRESUME THE SINGE TO THE PATIENT'S CHEEK OCCURRED WITHIN THIS END-USER CREATED OXYGEN RICH ENVIRONMENT. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED NOR CONFIRMED ANY MANUFACTURING DEFECTS ASSOCIATED WITH THE RETURNED DEVICES; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME. THE RETURNED ESU OPERATED AS INTENDED. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DURING SURGERY THE SURGEON STATED THAT THE UNIT ARCED AND A SPARK CAUGHT HIS GLOVE. DOCTOR WAS NOT HURT BUT THE PATIENT DID RECEIVE A SINGE MARK ON THE CHEEK - PATIENT WAS HAVING A LESION REMOVED. PATIENT WAS ON NASAL OXYGEN. UNIT WAS SET AT 15." IT WAS ALSO REPORTED THAT THE SINGE MARK ON CHEEK WAS TREATED (TREATMENT UNKNOWN) AND THE PATIENT WAS RELEASED THE SAME DAY OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 2450 ESU (ELECTROSURGICAL UNIT) ESU GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other