BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR

    MDR report key: 751 · Received June 22, 1992

    Report

    Report Number
    751
    Event Type
    Injury
    Date Received
    June 22, 1992
    Date of Event
    May 19, 1992
    Report Date
    June 1, 1992
    Manufacturer
    VALLEY LAB,INC.
    Product Code
    BWA
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT. RECEIVED BURN TO LOWER LIP REQUIRING INTRAOPERATIVE RECONSTRUCTION SURGERY TO LOWER LIP. DURING SET FOR SCHEDULED PROCEDURE, THE ELECTROSURGICAL GENERATOR HOOKED TO THE KELPINGER FORCEPS BURNED THE PATIENT. THE PATIENT'S FAMILY WAS ADVISED OF THE INCIDENT AND HAVE BEEN FOLLOWED UP WITH SINCE THAT TIME. THE ESU WAS CHECKED IN ACCORDANCE WITH THE MANUFACTURER RECOMMENDATIONS. ALL OUTPUTS WERE WITHIN THE REQUIRED SPECIFICATIONSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-92. SERVICE PROVIDED BY: INDEPENDENT SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL GENERATOR BWA VALLEY LAB,INC. FORCE 4B-2028587

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention