BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 208340 · Received January 29, 1999

    Report

    Report Number
    2916288-1999-00001
    Event Type
    Injury
    Date Received
    January 29, 1999
    Date of Event
    December 7, 1998
    Report Date
    December 14, 1998
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    JOS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING OTOPLASTY BILATERIAL EARS SURGICAL PROCEDURE, PHYSICIAN NOTICED A 0.5 CM BURNED AREA AT SKIN EDGE WHILE USING AN ELECTROSURGICAL UNIT WITH A NEEDLE TIP. NEEDLE TIP WAS REMOVED FROM FIELD IMMEDIATELY. EXCISION SITE WAS EXTENDED A LITTLE MORE THAN INTENDED TO INCLUDE ADD'L BURNED AREA CAUSED BY NEEDLE TIP. HOSPITAL'S BIOMEDICAL ENGINEERING EXAMINED THE NEEDLE TIP ELECTRODE AND NOTED A 0.65 MM BY 0.86 MM TRIANGULAR AREA OF MISSING INSULATION NEAR THE TIP OF THE ELECTRODE. THERE WAS ALSO AN ACCUMULATION OF CHARRED MATERIAL AT THE TIP OF THE NEEDLE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN ELECTROSURGICAL NEEDLE TIP ELECTRODE JOS OLSEN ELECTROSURGICAL, INC. 670 026938

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R