BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL COAG/SUCTION TUBE

    MDR report key: 9365 · Received August 11, 1993

    Report

    Report Number
    9365
    Event Type
    Injury
    Date Received
    August 11, 1993
    Date of Event
    February 18, 1993
    Report Date
    July 29, 1993
    Manufacturer
    WECK & COMPANY
    Product Code
    KCB
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 2/18/93, DURING A TONSIL AND ADENOID OPERATION ON A 13 YEAR OLD FEMALE PATIENT, THE SURGEON REPORTED A FLASH WHEN USING AN ELECTROSURGICAL UNIT. THE PATIENT SUSTAINED A BURN ON THE INNER RIGHT ASPECT OF HER MOUTH.THE ACTURAL PRODUCT HAD BEEN DISCARDED, BUT THE MANUFACTURER WAS NOTIFIED OF THE INCIDENT. THEY EVALUATED A SAMPLE FROM THE SAME LOT AND FOUND IT TO BE WITHIN MANUFACTURER SPECIFICATIONS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL COAG/SUCTION TUBE KCB WECK & COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention