BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-STICK MIRROR FINISH BIPOLAR FORCEPS

    MDR report key: 647160 · Received November 18, 2005

    Report

    Report Number
    1226348-2005-00271
    Event Type
    Injury
    Date Received
    November 18, 2005
    Date of Event
    October 17, 2005
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFFILIATE REPORTS THAT DURING A FACIAL TUMORECTOMY A FACIAL NERVE WAS BURNED AT THE CONTACT SURFACE OF THE BIPOLAR FORCEP. THIS EVENT DID NOT AFFECT THE FUNCTION OF THE PT'S FACIAL NERVE. THE HOSP WAS NOT CERTAIN AS TO WHAT INSTRUMENT WAS INVOLVED. THE SECOND INSTRUMENT NOTED ON THE COMPLAINT IS PRODUCT CODE 80-2941. BOTH INSTRUMENTS ARE NON INSULATED BIPOLAR FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-STICK MIRROR FINISH BIPOLAR FORCEPS ELECTROSURGICAL, CUTTING & COAG & ACCESSORIES GEI JOHNSON & JOHNSON PROFESSIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention