BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB FORCE 2

    MDR report key: 1652485 · Received April 1, 2010

    Report

    Report Number
    MW5015445
    Event Type
    Injury
    Date Received
    April 1, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 1, 2010
    Manufacturer
    TYCO HEALTHCARE GROUP LP
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN FOR ADENOTONSILLECTOMY RELATED TO RECURRENT TONSILLAR INFECTIONS AND SLEEP DISORDER BREATHING. THE PT REC'D BURNS IN THE SHAPE OF THE CROWE-DAVIS RETRACTOR AT THE END ON THE CASE. THE ELECTRIC SURGICAL UNIT WAS CHECKED IMMEDIATELY AND NO DEFICIENCY WAS DETERMINED. IN USE AT THE TIME WAS VALLEYLAB SUCTION COAGULATOR LOT NUMBER 149740 REFERENCE CATALOG E2505-10 FR. HAND HELD SUCTION IS POSITIONED CLOSE TO THE ELECTRICAL CURRENT BUTTON ALLOWING IT TO BE EASILY DISCHARGE CURRENT WHEN INTENTION IS TO SUCTION. THE HAND CONTROL CAN BE USED IN CONJUNCTION WITH FOOT CONTROL. THERE IS NO OVER-RIDE BOTH CAN BE ENGAGED AT THE SAME TIME. ELECTRO SURGICAL GENERATOR VALLEYLAB FORCE 2 (B) (4) - UNIT CHECKED BY BIO-MED IN HOUSE AND NO DEFICIENCIES FOUND-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB FORCE 2 SUCTION COAGULATOR GEI TYCO HEALTHCARE GROUP LP 149740
    2 VALLYLAB FORCE 2 ELECTRO SURGICAL GENERATOR GEI TYCO HEALTHCARE GROUP LP

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| S