BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN MIRROR FINISH BIPOLAR FORCEP

    MDR report key: 250367 · Received November 17, 1999

    Report

    Report Number
    1219655-1999-00191
    Event Type
    Malfunction
    Date Received
    November 17, 1999
    Date of Event
    October 13, 1999
    Report Date
    November 17, 1999
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    GEI
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORT#310045-99-004 REPORTS BIPOLAR FORCEPS BURNED THE INSIDE OF THE PT'S MOUTH DURING A TONSILECTOMY. BIOMEDICAL ENGINEER NOTED THAT THE FORCEPS LIKELY CONTACTED NON-TARGETED TISSUE DURING COAGULATION OR CAUTERY OF THE TONSIL. VOICE MAIL MESSAGE RECEIVED FROM USER FACILITY INITIAL REPORTER CONFIRMED THAT PRIMARY OBJECT OF MDR (IE. DEVICE RESPONSIBLE FOR EVENT) IS BIPOLAR FORCEP; CATALOG NO. 80-2961. NOTE: THIS IS THE SAME DEVICE THAT WAS INVOLVED IN AN EVENT REPORTED ON MFG MEDWATCH REPORT NO. 1219655-1999-00181. THE DEVICE WAS INVOLVED IN TWO SEPARATE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN MIRROR FINISH BIPOLAR FORCEP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI JOHNSON & JOHNSON PROFESSIONAL, INC. NA 9909N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CMC-I ELECTROSURGICAL GENERATOR, PRODUCT CODE UNK.