BEUDAMED
    FDA Adverse Event Death Summary report: N

    HELIXAR ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR, 120V

    MDR report key: 6326979 · Received February 13, 2017

    Report

    Report Number
    1017294-2017-00012
    Event Type
    Death
    Date Received
    February 13, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 13, 2017
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K152860
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXTENSIVE ONSITE EVALUATION INVOLVING A TEAM CONSISTING OF THE R&D AND QUALITY ENGINEERS ALONG WITH THE FACILITY BIOMED ENGINEER FOUND THE ELECTROSURGICAL UNIT PERFORMED AS INTENDED WITH NO ABNORMALITIES OR PROBLEMS NOTED. THE HELIXAR ELECTROSURGICAL UNIT WAS THEN RETURNED TO CONMED FOR EVALUATION ON 09-FEB-2017. A THOROUGH EVALUATION AND FUNCTIONAL TESTING OF THE RETURNED UNIT WERE AGAIN PERFORMED MULTIPLE TIMES TO ENSURE THE OUTPUT POWER AND OTHER OUTPUT PARAMETERS WERE REPEATABLE AND FUNCTIONED AS DESIGNED. FINAL TEST RESULTS SHOWED THE UNIT PERFORMED TO SPECIFICATIONS AND PASSED ALL FUNCTIONAL TEST REQUIREMENTS WITH NO ABNORMALITIES NOTED. A REVIEW OF THE SERVICE REPAIR HISTORY FOR THIS DEVICE FOUND THE UNIT WAS MANUFACTURED ON 06-OCT-2016 WITH NO SERVICE/REPAIR HISTORY FOUND. IN ADDITION, A REVIEW OF THE DEVICE COMPLAINT HISTORY FOR THE ELECTROSURGICAL UNIT SHOWED NO OTHER SIMILAR COMPLAINTS RECEIVED. OTHER THAN THIS ALLEGED INCIDENT, TO DATE THERE HAVE BEEN NO SERIOUS INJURY OR DEATH RELATED TO THE REPORTED PROBLEM OR THE USE OF THE DEVICE. THIS IS AN ISOLATED INCIDENT AND THE ALLEGATION THAT THE ELECTROSURGICAL UNIT MIGHT HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED INCIDENT IS UNCONFIRMED. TO REDUCE THE RISK OF INJURY TO THE PATIENT, THE DEVICE INSTRUCTION MANUAL PROVIDES THE FOLLOWING PRECAUTIONS AND WARNINGS: - KEEP THE PROBE TIP AT LEAST 3 MM (0.12 IN) AWAY FROM THE TISSUE, OR PER ACCESSORY INSTRUCTIONS, AND AT A 45- 60 DEGREE ANGLE DURING ARGON BEAM COAGULATION. BE SURE TO USE THE LOWEST GAS FLOW NECESSARY FOR THE DESIRED COAGULATION EFFECT. TO REDUCE THE POSSIBILITY OF GAS EMBOLISM, MOVE THE PROBE AWAY FROM TISSUE BETWEEN ACTIVATIONS. - WITH ARGON BEAM COAGULATION, RISK OF GAS EMBOLISM RISES WHEN THERE IS INSUFFICIENT RADIO-FREQUENCY OUTPUT POWER TO PRODUCE RAPID HEMOSTASIS ON THE TARGET TISSUE. - ARGON DISSECT SHOULD ONLY BE USED WITH THE ARGON DISSECTING ELECTRODE ACCESSORY ATTACHED TO THE COMPATIBLE ABC HANDPIECES. NOT DOING SO MAY RESULT IN EXCESSIVE ARGON FLOW, POTENTIALLY CAUSING AN EMBOLISM. IN ADDITION, THE INSTRUCTIONS FOR USE (IFU) ON THE ABC BEND-A-BEAM HANDPIECE PROVIDE THE FOLLOWING WARNINGS AND PRECAUTIONS: -VENOUS GAS EMBOLI MAY BE PRODUCED WHILE UTILIZING ARGON BEAM COAGULATION. TO LOWER THE RISK OF GAS EMBOLI, DO NOT USE ARGON BEAM COAGULATION FOR PROLONGED PERIODS, DO NOT ALLOW ARGON GAS FLOW TO MAKE DIRECT CONTACT WITH OPEN VESSELS, SET THE GAS FLOW TO THE LOWEST SETTING CAPABLE OF ACHIEVING THE DESIRED CLINICAL EFFECT, DO NOT ALLOW ARGON GAS TO FLOW FOR MORE THAN T SECONDS WITHOUT CUTTING OR COAGULATING TISSUE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN OPEN "EXPLORATORY LAPAROTOMY PROCEDURE AND REMOVAL OF CYSTS FROM LIVER LOBES 3 AND 4, WHILE THE SURGEON WAS PERFORMING A CHOLANGIOGRAM, THE PATIENT'S BLOOD PRESSURE DROPPED. CHEST COMPRESSION AND CPR WERE PERFORMED TO STABILIZE THE PATIENT. DESPITE THE EFFORTS, THE PATIENT EXPIRED. AS REPORTED, THE EXPLORATORY LAPAROTOMY PROCEDURE HAD ALREADY STARTED FOR OVER AN HOUR, WHEN THE SURGEON DECIDED TO PERFORM A CHOLANGIOGRAM. IT IS UNKNOWN TO CONMED AT WHAT STAGE OF THE PROCEDURE THAT THE BEND-A-BEAM HANDPIECE AND THE HELIXAR ELECTROSURGICAL UNIT WERE USED, ONLY THAT THE ABC DEVICE WAS USED BECAUSE THE SURGEON "CREATED A SMALL NICK WITH HIS PICKUP" WHILE TRYING TO PERFORM THE CHOLANGIOGRAM. FOLLOW UP DISCUSSION WITH THE SURGEON AFTER THE INCIDENT REVEALED THAT THE SURGEON WAS OPERATING "IN THE VICINITY OF THE GALLBLADDER" AND HE NOTED "THERE WERE NO BIG VESSELS" IN THIS AREA. THE SURGEON ALSO STATED THAT HE IS AN EXPERIENCED ABC USER AND WAS USING BEND-A-BEAM WITH A BACK AND FORTH MOTION AND AT A DISTANCE OF APPROXIMATELY 5 MM FROM THE PATIENT'S TISSUE. SHORTLY THEREAFTER, THE PATIENT'S BLOOD PRESSURE DROPPED AND AFTER APPROXIMATELY 5 MINUTES OF CHEST COMPRESSIONS, SHE EXPIRED. OTHER RECEIVED INFORMATION INDICATED THAT THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AT SOME POINT ON THE PATIENT AND THAT THE SURGEON REPORTEDLY SAW "A BIG EMBOLISM" AND THIS WAS VISUALIZED IN THE HEART, AORTA". AS OF THIS FILING, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT MEDICAL HISTORY AND/OR ANY PRE-EXISTING CONDITIONS PRIOR TO THE SURGERY ON (B)(6) 2017. IT IS ALSO UNKNOWN TO CONMED WHAT OTHER MEDICAL DEVICE INSTRUMENTS AND EQUIPMENT WERE BEING UTILIZED DURING THE MENTIONED PROCEDURES. THE CONCOMITANT 6" BEND-A-BEAM ABC HANDPIECE (ITEM #134006) IS BEING REPORTED ON MDR #3007305485-2017-00023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108728 HELIXAR ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR, 120V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death A 6" BEND-A-BEAM ABC HP., ITEM #134006 LOT #: UNK