BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL SYSTEMS

    MDR report key: 234955 · Received August 6, 1999

    Report

    Report Number
    1720159-1999-00062
    Event Type
    Injury
    Date Received
    August 6, 1999
    Date of Event
    April 8, 1997
    Report Date
    July 12, 1999
    Manufacturer
    ASPEN LABORATORIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF A ROUTINE ADENOTONSILLECTOMY, THE PT SUSTAINED A BURN TO THE RIGHT ORAL COMMISSURE. THE SPECIFIC BOVIE TIP USED WAS AN INSULATED TIP WITH ONLY THE VERY END OF THE SPATULA NOT INTO THE BOVIE HANDLE. THE TIP, AT NO TIME, CAME INTO CONTACT WITH THE AREA THAT WAS BURNED. THE OPERATING ROOM NURSE FELT THAT SHE HAD INSERTED THE TIP CORRECTLY AND COMPLETELY. EXAMINATION OF THE INSTRUMENT IMMEDIATELY AFTER THE BURN WAS NOTICED, DEMONSTRATED THAT THE TIP APPEARED TO BE COMPLETELY INSULATED WITH INSULATION UP INTO THE OPEN END OF THE HAND-CONTROLLED CAUTERY. IT WAS FELT, AT THAT TIME, THAT THE TIP MAY HAVE BEEN ABLE TO BE ADVANCED ANOTHER MILLIMETER, OR SO, INTO THE BOVIE HANDLE, BUT, THE INSULATION APPEARED TO BE COVERING THE JUNCTION AREA. THE PT REQUIRED REHABILITATION WITH AN ORAL COMMISSURE SPLINT AND IT DID RESULT IN THE PAYOUT OF A SETTLEMENT THROUGH THE DR'S INSURANCE CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL SYSTEMS ELECTROSURGICAL PENCIL GEI ASPEN LABORATORIES, INC. HAND-TROL *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention