BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E.S. UNIT, POWER CONTROL

    MDR report key: 1030034 · Received April 14, 2008

    Report

    Report Number
    1717344-2008-00153
    Event Type
    Injury
    Date Received
    April 14, 2008
    Report Date
    March 19, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE CONTACTED OUR CLINICAL HOT-LINE ABOUT THE OCCURRENCE, AND THEY CONFIRMED THERE WAS THE POSSIBILITY THAT AN INDUCED CURRENT OCCURRED WHEN THEY WRAPPED THE PENCIL CORD AROUND THE CLAMP. THE SITE HAS REQUESTED AN IN-SERVICE FOR THEIR STAFF BY COVIDIEN. THE GENERATOR MANUAL STATES: WARNING - DO NOT WRAP THE ACCESSORY CORDS OR PATIENT RETURN ELECTRODE CORDS AROUND METAL OBJECTS. THIS MAY INDUCE CURRENTS THAT COULD LEAD TO SHOCKS, FIRES, OR INJURIES TO THE PATIENT OR SURGICAL TEAM.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING AN ABDOMINAL HYSTERECTOMY IN THE SUPINE POSITION, THEY HAD AN ES PENCIL CABLE PLACED OVER THE ABDOMEN, AND THE PENCIL CABLE WRAPPED AROUND AN ALICE CLAMP USED TO SECURE THE DRAPES. WHEN THE FIRST PENCIL WAS IN USE, THE SURGEON COMPLAINED THAT SHE WAS NOT GETTING THE AMOUNT OF POWER THAT SHE WAS USED TO. THEY REPLACED THE FIRST PENCIL WITH ANOTHER. ONLY THE 2ND PENCIL WAS SAVED, AND THE CABLE ON THIS PENCIL HAD EVIDENCE THAT THE ALICE CLAMP WAS CLAMPED ONTO THE CABLE SHOWING THE JAW OR TEETH MARKS OF THE CLAMP, BUT NO NICK OR CUT INTO THE CABLE. THE BIOMED DID A HIGH POT TEST ON THIS CABLE AND IT WAS WITHIN NORMAL LIMITS. THE SITE CONCLUSION WAS THAT THIS INJURY WAS DUE TO THE CURRENT FLOWING FROM THE CABLE, THROUGH THE METAL CLAMP TO THE PATIENT WHO RECEIVED 3RD DEGREE BURN, THE SIZE OF A QUARTER ON LEFT CHEST UNDER BREAST ON RIBS AND WAS NOTED WHEN DRAPES WERE REMOVED. THE GENERATOR WAS SET AT CUT 20 AND COAG 30.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PATIENT RETURN ELECTRODE - LOT # UNKNOWN