BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1720159-1999-00158

    MDR report key: 257289 · Received December 28, 1999

    Report

    Report Number
    1720159-1999-00158
    Event Type
    Malfunction
    Date Received
    December 28, 1999
    Date of Event
    December 13, 1999
    Report Date
    December 14, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY & ADENOIDECTOMY, THE SAME THING HAPPENED AS HAPPENED ON 12/06/1999, ONLY USING AN MF-450 AND A VALLEY LAB PENCIL. WHEN THE PENCIL WAS BEING WITHDRAWN IT IGNITED (DESCRIBED AS A BALL OF FIRE). IT CHARRED THE TIP OF THE PENCIL BUT DID NOT BURN THE PT. REFER TO 1720159-1999-00156 AND -00157 FOR THE EVENT ON 12/06/1999.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA VALLEY LAB ELECTROSURGICAL PENCIL.