BEUDAMED
    FDA Adverse Event Death Summary report: N

    6" BEND-A-BEAM MALEABLE ABC HANDPIECE

    MDR report key: 6326933 · Received February 13, 2017

    Report

    Report Number
    3007305485-2017-00023
    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
    K961505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) ABC BEND-A-BEAM HANDPIECE WAS RETURNED TO THE CONMED FOR EVALUATION ON 02-FEB-2017. THE DEVICE WAS EXAMINED AND FUNCTIONALLY TESTED IN THE LABORATORY. VISUAL INSPECTION NOTED NO VISIBLE DEFECTS OR DAMAGE TO THE RETURNED DEVICE. FUNCTIONAL TEST SHOWED THE UNIT PERFORMED TO SPECIFICATIONS AND PASSED ALL TEST REQUIREMENTS WITH NO DEFECTS IDENTIFIED, THEREFORE THIS COMPLAINT IS UNCONFIRMED. THE MANUFACTURING DATE, LOT SIZE AND REVIEW OF THE MANUFACTURING DOCUMENTS WERE NOT OBTAINABLE AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. A 2-YEAR REVIEW OF THE DEVICE FAMILY SHOWED NO OTHER SIMILAR COMPLAINTS RECEIVED. (B)(4). 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 USE OF THE ABC BEND-A-BEAM HANDPIECE AND THE ELECTROSURGICAL UNIT MIGHT HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED INCIDENT IS UNCONFIRMED. THE ABC BEND-A-BEAM SINGLE FUNCTION HANDPIECES HAVE APPLICATIONS IN OPEN ELECTROSURGICAL PROCEDURES TO PROVIDE A MEANS OF COAGULATION. TO REDUCE THE RISK OF INJURY TO THE PATIENT, THE INSTRUCTIONS FOR USE (IFU) 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 HELIXAR ELECTROSURGICAL UNIT (ITEM #60-8800-120) IS BEING REPORTED ON MDR #1017294-2017-00012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108306 6" BEND-A-BEAM MALEABLE ABC HANDPIECE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death HELIXAR ELECTROSURGICL UNIT 60-8800-120 SN(B)(4)