BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E.S. UNIT, POWER CONTROL

    MDR report key: 1163294 · Received September 9, 2008

    Report

    Report Number
    1717344-2008-00412
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 13, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE GENERATOR WAS TESTED ON THE AUTOMATED SAFETY TESTER AND FUNCTIONED NORMALLY AND WITHIN SPECIFICATION. THE GENERATOR WAS POWERED UP AND WENT THROUGH SELF TEST NORMALLY. A VISUAL INSPECTION OF THE GENERATOR FOUND THAT MULTIPLE BUTTONS ON THE MONOPOLAR KEYBOARD OVERLAY WERE CRACKED BUT THIS CONDITION DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED CONDITION. THIS GENERATOR IS OBSOLETE AS OF JULY 2005. INITIAL TESTING FOUND SEVERAL OUT OF SPECIFICATION CONDITIONS. THESE CONDITIONS DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED CONDITION. COVIDIEN ADDRESSES SETUP, OPERATION AND WARNINGS CONCERNING ELECTROSURGICAL EQUIPMENT AND PATIENT/STAFF SAFETY IN THE IFU. COVIDIEN HAS ISSUED A HOTLINE BULLETIN ADDRESSING COMMON ISSUES AND THEIR CAUSES PERTAINING TO ELECTROSURGERY AND PATIENT/STAFF SAFETY WHICH CAN BE FOUND ONLINE. THIS INFORMATION HAS BEEN PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING INSERTION OF A VENOUS PORT TO THE RIGHT CHEST, AND AFTER THE INITIAL INCISION, THE FIRST ACTIVATION AT THE USUAL 30W CUT/30W COAG SEEMED VERY HIGH TO THE SURGEON, AND HE ASKED IT TO BE TURNED DOWN TO 15W. ON THE NEXT ACTIVATION, THE END OF THE TIP SPARKED/FLAMED YELLOW AND CAUGHT A LAP SPONGE ON FIRE. THEY SHUT OFF THE O2 (SET AT BETWEEN 3-5 L) AND THE SURGEON PADDED OUT THE FIRE. THE PT REC'D A 2ND DEGREE BURN WHICH WAS TREATED WITH SILVADENE. THE O2 HAD BEEN WALLED OFF FROM THE SURGICAL SITE WITH A TOWEL. THE PREP WAS A BETADINE GEL. ABOUT 1/2 OF THE SPONGE WAS BURNED. THEY GOT A NEW PENCIL AND NEW GENERATOR AND COMPLETED THE PROCEDURE. THE PENCIL WAS NOT SAVED BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E.S. UNIT, POWER CONTROL ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B) (4) - COVIDIEN LP ELECTROSUGICAL PENCIL,| LOT# UNK.