BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUCTION COAGULATOR, FOOT CONTROL, 10 FR, 6", MONOPOLAR, SINGLE USE, STERILE

    MDR report key: 5290124 · Received December 11, 2015

    Report

    Report Number
    3007305485-2015-00035
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 12, 2015
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K033003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) USED SUCTION COAGULATOR WAS RETURNED TO CONMED ON 12-NOV-2015 FOR EVALUATION. ON ARRIVAL AT CONMED THE DEVICE WAS VISUALLY INSPECTED AND NO INSULATION DEFECT WAS OBSERVED ON THE DEVICE. THE INSULATION HAD SOME SCRATCHES IN THE INSULATION AS IF IT HAD BEEN IN CONTACT WITH THE PATIENT'S TEETH OR OTHER HARD OR SHARP OBJECT; HOWEVER, THE INSULATION APPEARED INTACT WITH NO EXPOSED AREAS OF THE METAL SHAFT NOTED WHERE INSULATED. THE DEVICE WAS SENT TO (B)(4), THE MANUFACTURER OF THE DEVICE FOR A FULL EVALUATION ON 23-NOV- 2015. TO DATE A REPORT FROM (B)(4)HAS NOT BEEN RECEIVED AT CONMED. ON COMPLETION OF CONMED'S QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED INCIDENT A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ONE (1) "USED" SUCTION COAGULATOR, FOOT CONTROL, WAS RECEIVED AT (B)(4) FOR EVALUATION. ON ARRIVAL AT (B)(4) THE DEVICE WAS VISUALLY INSPECTED AND NO INSULATION DEFECT WAS OBSERVED ON THE DEVICE. THE INSULATION HAD SOME SCRATCHES IN THE INSULATION AS IF IT HAD BEEN IN CONTACT WITH THE PATIENT'S TEETH OR OTHER HARD OR SHARP OBJECT; HOWEVER, THE INSULATION APPEARED INTACT WITH NO EXPOSED AREAS OF THE METAL SHAFT NOTED WHERE INSULATED. THE DEVICE WAS SENT TO MODERN MEDICAL EQUIPMENT MFG., LTD., THE MANUFACTURER OF THE DEVICE FOR A FULL EVALUATION ON 23-NOV- 2015. THE DEVICE INVESTIGATION BY THE OEM PERFORMED ON THE RETURNED DEVICE AND ON RETAINED SAMPLES FROM THE SIX (6) POSSIBLE LOTS OF SUCTION COAGULATORS SHOWED ALL DEVICES PASSING ALL ELECTRICAL TESTS PERFORMED. THERE WERE NO MANUFACTURING DEFECTS FOUND ON THE ACTUAL RETURNED DEVICE OR THE SEVENTEEN (17) SAMPLES FROM THE IDENTIFIED LOTS. TESTING VERIFIED THAT THERE WAS NO BREAKDOWN OF INSULATION ON ANY OF THE TESTED DEVICES; THEREFORE, THE COMPLAINT REGARDING A DEFECT IN THE DEVICE'S INSULATION COATING IS UNCONFIRMED. POSSIBLE CAUSES OF THE REPORTED SECOND DEGREE BURN TO THE PATIENT'S TONGUE COULD INCLUDE AN ACCIDENTAL ACTIVATION OF THE DEVICE WHILE THE DEVICE TIP WAS IN CONTACT WITH THE PATIENT'S TONGUE, OR, AN INADVERTENT TOUCHING OF THE TONGUE WITH THE DEVICE TIP AFTER A RECENT ACTIVATION. THE DEVICE COULD BE HOT ENOUGH AFTER ACTIVATION TO RESULT IN A SECOND DEGREE BURN TO THE PATIENT'S TONGUE. THE FINISHED DEVICE WAS PACKAGED BY (B)(4) ON 09-SEP-2015. A REVIEW OF THE PACKAGING DHR FOUND NO NOTED DISCREPANCIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED EVENT. THE OEM (MMEQ) REVIEWED SIX DHRS OF THE POSSIBLE LOTS OF FINISHED GOODS INCLUDED WITHIN THE CONMED PACKAGING DHR AND ALSO NOTED NO DISCREPANCIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED EVENT. OF THE CONMED LOT CONTAINING (B)(4) UNITS, THERE HAS ONLY BEEN THIS ONE (1) REPORT OF A PATIENT BURN. A TWO YEAR REVIEW OF COMPLAINT HISTORY FOR THIS DEVICE FAMILY SHOWED A TOTAL OF FOUR (4) SIMILAR REPORTS FOR PATIENT BURNS, INCLUDING THIS REPORTED EVENT. DURING THIS SAME TWO YEAR PERIOD OVER (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS FAILURE MODE (B)(4). TO DATE THERE HAVE BEEN NO LONG TERM ADVERSE EVENTS REPORTED REGARDING ANY OF THE (B)(4) REPORTED INCIDENTS. THE DEVICE IN QUESTION, THE SUCTION COAGULATOR, FOOT CONTROL, 10 FRENCH, 6" (152MM), MONOPOLAR, SINGLE USE; STERILE, IS DESIGNED TO PROVIDE COAGULATION THERAPEUTIC ENERGY TO TISSUE, AND, SUCTION TO ASPIRATE BLOOD, COAGULUM AND SMALL BITS OF TISSUE DEBRIS FROM THE SURGICAL SITE. TO REDUCE THE RISK OF PATIENT INJURY, THE IFU, INSTRUCTIONS FOR USE) PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: ALWAYS PLACE UNUSED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION SUCH AS A HOLSTER WHEN NOT IN USE. AFTER ACTIVATION THE SUCTION COAGULATOR MAY BE HOT AND CARE SHOULD BE TAKEN TO PREVENT ACCIDENTAL BURNS. DO NOT ACTIVATE THE ELECTROSURGICAL UNIT IF THE TIP OF THE INSTRUMENT IS NOT IN A POSITION TO DELIVER ENERGY TO TARGET TISSUE. DOING SO MAY CAUSE INADVERTENT BURNS TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CONMED THAT DURING USE OF THE SUCTION COAGULATOR IN A TONSILLECTOMY PROCEDURE AND WHILE CAUTERIZING THE TONSIL BEDS, THE SURGEON NOTICED A GRAYISH AREA ON THE PATIENT'S TONGUE. REPORTEDLY, THE SURGEON INSPECTED THE SUCTION COAGULATOR AND IDENTIFIED A DEFECT IN THE INSULATION COATING OF THE WAND OF THE DEVICE. THE BURN TO THE PATIENT'S TONGUE WAS IDENTIFIED AS A SECOND DEGREE BURN. HOWEVER, NO TREATMENT WAS ADMINISTERED TO THE BURN. FOLLOW-UP INFORMATION RECEIVED FROM THE USER FACILITY INDICATED THAT THE PATIENT IS STABLE AND HEALING FROM THE SURGERY AND THE BURN TO THE TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820111 SUCTION COAGULATOR, FOOT CONTROL, 10 FR, 6", MONOPOLAR, SINGLE USE, STERILE SUCTION COAGULATOR GEI CONMED ELECTROSURGERY 201509094

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other