BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDSWITCH PENCIL

    MDR report key: 2221478 · Received August 17, 2011

    Report

    Report Number
    1717344-2011-00702
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 20, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL OF THE INCIDENT DEVICE FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. NOTHING WAS IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN MADE, BUT THE CUSTOMER HAS NOT RESPONDED. THE IFU STATES TO ALWAYS PLACE THE ACTIVE ACCESSORY IN A CLEAN DRY INSULATED SAFETY HOLSTER WHEN NOT IN USE. ELECTROSURGICAL ACCESSORIES THAT ARE ACTIVATED OR HOT FROM USE CAN CAUSE UNINTENDED BURNS TO THE PT OR SURGICAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GENERATOR WAS SET AT 45W COAG, 45W CUT. THE VOLUME WAS TURNED DOWN ALL THE WAY ON THE GENERATOR SO NO TONES COULD BE HEARD. THERE WAS A HOLSTER IN THE STERILE FIELD BUT IT WAS NOT BEING USED. AFTER COMPLETING THE SURGERY AND CLOSING THE INCISION, THE SURGEON PICKED UP THE PENCIL TO COAGULATE BLEEDERS AND NOTICED THAT THE DEVICE WAS ACTIVATED W/O THE BUTTON BEING PUSHED. THE SOUND WAS TURNED UP ON THE GENERATOR AND AN ACTIVATION TONE WAS HEARD. THE PENCIL WAS UNPLUGGED AND PLUGGED BACK IN AND THE ACTIVATION TONE STOPPED. THE SURGEON CONTINUED TO USE THE PENCIL AND THEN LAID THE PENCIL ON THE PT'S STOMACH. THE PT SUSTAINED A BURN FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDSWITCH PENCIL ES ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR FORCETRIAD GENERATOR, S/N (B)(4)