BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REUSABLE ELECTRODE EXTENDER

    MDR report key: 3856 · Received February 2, 1993

    Report

    Report Number
    3856
    Event Type
    Injury
    Date Received
    February 2, 1993
    Date of Event
    November 27, 1992
    Report Date
    December 1, 1992
    Manufacturer
    BIRTCHER MEDICAL SYSTEMS, INC.
    Product Code
    HIM
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    FORTY-EIGHT YEAR OLD WOMAN IN GOOD CONDITION TO OR FOR LEFT BREAST REVISION RECONSTRUCTION. DURING THE PROCEDURE WHILE THE PHYSICIAN WAS CAAUTERIZATING USING THE EXTENSION, A SPARK OCURRED CAUSING A BURN AT THE CAUTERY SZITE. THE BURNED AREA WS EXCISED. THE EXTENDER WAS EXAMINED FOR CRACKS IN THE INSULATION AND NONE WAS FOUNDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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, OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE ELECTRODE EXTENDER ELECTROCAUTERY EXTENSION HIM BIRTCHER MEDICAL SYSTEMS, INC. SAME N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention