BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL SYSTEMS

    MDR report key: 372268 · Received January 18, 2002

    Report

    Report Number
    1720159-2001-00113
    Event Type
    Injury
    Date Received
    January 18, 2002
    Date of Event
    December 21, 2001
    Report Date
    December 21, 2001
    Manufacturer
    CONMED/ASPEN LABS
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE PATIENT EXPERIENCED A PERIPHERAL ORAL BURN. SPARK FLEW FROM PENCIL BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL SYSTEMS ELECTROSURGICAL PENCIL GEI CONMED/ASPEN LABS HAND-TROL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other