BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL COAGULATION SUCTION TUBE W/STYLET

    MDR report key: 2442 · Received February 15, 1993

    Report

    Report Number
    2442
    Event Type
    Injury
    Date Received
    February 15, 1993
    Date of Event
    January 26, 1993
    Report Date
    February 3, 1993
    Manufacturer
    EDWARD WECK, INC.
    Product Code
    EKZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    FLASH FIRE OCCURRED IN ORAL CAVITY-FLAMES WERE SIMUTANEOUSLY EXTINGUISHED. CAUTERY WAS REMOVED STAT FROM FIELD AND CAUTERY MACHINE DISCONNECTED. PATIENT WAS EXTUBATED AND INTUBATED PER ANESTHESIA. IN PACU, A SMALL BURN WAS NOTED ON LEFT LATERAL ASPECT OF TONGUE. EXAMINED BY DR., NO TREATMENT NEEDEDDEVICE 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL COAGULATION SUCTION TUBE W/STYLET EKZ EDWARD WECK, INC. 809610 2H1566

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention