BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN BIOSURGICAL BIPOLAR CORD

    MDR report key: 878999 · Received July 6, 2007

    Report

    Report Number
    1061133-2007-00001
    Event Type
    Injury
    Date Received
    July 6, 2007
    Date of Event
    June 11, 2007
    Report Date
    July 5, 2007
    Manufacturer
    AMERICAN BIOSURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K953889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS NOT ABLE TO OBTAIN ANY FURTHER INFO CONCERNING THE REPORTED EVENT OR RETRIEVE THE "SUSPECT" CABLE FOR ANALYSIS FROM THE END-USER. THIS IS THE FIRST REPORT OF SUCH AN OCCURRENCE FOR THIS REPORTED "SUSPECT" CABLE OUT OF FIVE MILLION DISTRIBUTED IN THE PAST FIVE YEARS. CABLES MANUFACTURED ARE TESTED AND INSPECTED TO APPLICABLE INTERNATIONAL PERFORMANCE STANDARDS PRIOR TO SHIPMENT. THIS CABLE IS A SINGLE-USE DISPOSABLE LOW FREQUENCY BIPOLAR TYPE AND IT IS UNLIKELY THAT A CABLE OF THIS NATURE WOULD SPARK WHEN USED CORRECTLY. THE MANUFACTURER WILL CONTINUE TO ATTEMPT IN OBTAINING FURTHER INFO FROM THE USER SITE SO A COMPREHENSIVE INVESTIGATION AND ROOT CAUSE ANALYSIS MAY BE PERFORMED. THE MANUFACTURER IS PRESENTLY EVALUATING AND TESTING CABLES THAT ARE IDENTICAL AS THE ONE USED DURING THE REPORTED EVENT. A FOLLOW-UP REPORT WILL BE PROVIDED TO THE AGENCY WHEN NEW INFO IS MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTRO-SURGICAL PROCEDURE IN THE OPERATING ROOM, THE DRAPE COVERING THE PT CAUGHT ON FIRE AND SUBSEQUENTLY RECEIVED A BURN. THE REPORTER "SUSPECTED" THAT THE BIPOLAR CORD SPARKED AND IGNITED THE DRAPE DURING THE PROCEDURE. THERE WAS NO INFO PROVIDED DETAILING THE PROCEDURE, PT SEX, AGE, DEGREE OF THE BURN SUSTAINED AND THE TREATMENT AFTER THE BURN, ELECTROSURGICAL UNIT AND BIPOLAR COMPONENTS USED DURING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN BIOSURGICAL BIPOLAR CORD BIPOLAR CABLE/CORD GEI AMERICAN BIOSURGICAL, INC. 001014

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention