BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED GOLDVAC PUSH BUTTON SMOKE EVACUATION PENCIL

    MDR report key: 2231516 · Received September 1, 2011

    Report

    Report Number
    1720159-2011-00050
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    December 2, 2011
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K081634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND OF THREE INCIDENTS REPORTED BY THE FACILITY. THEY WERE SUBMITTED AT THE SAME TIME, HOWEVER, DATES WERE NOT PROVIDED AND THE SAMPLES WERE DISCARDED. AT THIS TIME CONMED ELECTROSURGERY COULD NOT CONFIRM THE REPORTED MALFUNCTION.

    Additional Manufacturer Narrative · 1

    INITIALLY, IT WAS REPORTED THAT A CONMED PRODUCT (GOLDVAC) HAD SELF-ACTIVATED. LATER, CONMED RECEIVED INFORMATION STATING THAT THE CUSTOMER HAD PLACED THE PENCIL AGAINST ITS OWN BUTTONS WHICH CAUSED THE SELF-ACTIVATION. THERE IS NOT ANY INDICATION OF A MALFUNCTION OF A CONMED PRODUCT DURING THIS EVENT. THIS REPORT IS BEING SENT IN AFTER THE 30 DAY WINDOW FOR FOLLOW-UPS BECAUSE THERE WAS A DELAY IN HAVING A DUPLICATE SUBMISSION DELETED. FACILITY DISCARDED THE PRODUCT.

    Description of Event or Problem · 1

    THE GOLDVAC HAND PIECE HAD SELF-ACTIVATED.

    Description of Event or Problem · 1

    THE GOLDVAC HAND PIECE HAD SELF-ACTIVATED. THE CUSTOMER HAD PLACED THE PENCIL AGAINST ITS OWN BUTTONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED GOLDVAC PUSH BUTTON SMOKE EVACUATION PENCIL ELECTROSURGICAL SMOKE EVACUATION PENCIL GEI CONMED ELECTROSURGERY 1106143

    Patients

    Seq Age Sex Outcome Treatment
    1 Other