BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED

    MDR report key: 1315829 · Received February 12, 2009

    Report

    Report Number
    1720159-2009-00002
    Event Type
    Other
    Date Received
    February 12, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 16, 2009
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY HAS MADE THE DEVICE AVAILABLE FOR EVALUATION. HOWEVER, THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO CONMED ELECTROSURGERY AS OF 2009/02/11. OUR EVALUATION RESULTS WILL BE SUBMITTED TO THE FDA ONCE OUR INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY HAS STATED THE CONMED PENCIL (130318) (IN THE PD CATHETER PACK) WAS USED IN CONJUNCTION WITH ANOTHER CO'S DEVICE. THE PENCIL PRODUCED A "POP" NOISE FOLLOWED BY A TWO INCH FLAME WHICH BURNED/SINGED THE PT'S HAIR (LEFT ANTERIOR THIGH). THERE WAS NO BURN/INJURY TO THE PT. A PREP SOLUTION WAS USED PRIOR TO THE PROCEDURE, HOWEVER, THE NAME OF THIS SOLUTION WAS NOT DISCLOSED. ACCORDING TO THE USER FACILITY, THERE WAS NO DEBRIS ON THE TIP OF THE PENCIL. THE PENCIL WAS NEW AND HAD NOT BEEN USED. THE USER FACILITY, HAS REQUESTED NONDESTRUCTIVE TESTING TO BE PERFORMED ON THE SUSPECT DEVICE. CONMED ELECTROSURGERY HAS AGREED TO RETURN THE SUSPECT DEVICE TO USER FACILITY ONCE EVALUATION ACTIVITIES HAVE CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL GEI CONMED ELECTROSURGERY 0808281

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other VALLEY LAB FORCE (ESU)