BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGA2000 RETURN ELECTRODE

    MDR report key: 1141053 · Received August 29, 2008

    Report

    Report Number
    1721194-2008-00004
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 26, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    ODR
    PMA / PMN Number
    K982826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE REPORT, THE PRODUCT AND LOT HISTORIES WERE REVIEWED, AND REVEALED THIS TO BE A RELIABLE COMPONENT OF ELECTROSURGERY MANUFACTURED TO DEVICE MASTER RECORD SPECIFICATIONS, AND WE CAN FIND NO EVIDENCE TO SUGGEST A DEVICE DEFECT OR MALFUNCTION WHICH MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE IS STILL IN OPERATION AT FACILITY, AND USER REPORTS THERE IS NO EVIDENCE OF THERMAL DAMAGE TO DEVICE OR LINENS. THERE IS NO EVIDENCE TO SUGGEST A DEVICE FAILURE OR MALFUNCTION AND WE ARE UNABLE TO ESTABLISH A CAUSAL RELATIONSHIP BETWEEN THE PROPER INSTALLATION AND USE OF THE DEVICE AND THE REPORTED EVENT. THE MOST LIKELY CAUSE OF THE LESIONS IS RELATED TO THE CREATION OF AN ALTERNATE CURRENT PATH WITH THE USE OF THE TOWEL CLAMPS (AND/OR A PRESSURE LESION). THIS RISK IS INHERENT IN THE USE OF ELECTROSURGERY, IS WELL DOCUMENTED IN SCIENTIFIC LITERATURE, AND IS ADDRESSED IN THE INSTRUCTIONS FOR USE PROVIDED WITH THE DEVICE.

    Description of Event or Problem · 1

    DOCTOR USED MEGA2000 TO ANTERIOR FUSION AT NECK AND BUTTOCK WITH GENERATOR WHICH BRAND IS ASPEN, MODEL: MF380 UNDER POWER SETTING IN MODE CUT 30 / COAG 35 AND BIPOLAR 40. POSITION OF THE PT WAS SUPINE AND THERE WERE 2 BLANKETS WERE LAID OVER THE PAD. TOWEL CLAMP HAD BEEN LOCKED AT NECK AND BUTTOCK DURING OPERATION. IT TOOK 1 HOUR, AFTER THE SURGERY, THE PT ONLY RECEIVED BURN MARK AT BUTTOCK WHERE IT WAS LOCKED WITH TOWEL CLAMP FORCEP. HOSPITAL USED BETADINE SOLUTION IN PROCEDURE FOR DISINFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA2000 RETURN ELECTRODE REUSABLE RETURN ELECTRODE ODR MEGADYNE MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASPEN ELECTROSURGICAL GENERATOR MODEL MF380