BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERI-SYSTEMS CORPORATION

    MDR report key: 317300 · Received February 20, 2001

    Report

    Report Number
    MW1021143
    Event Type
    Other
    Date Received
    February 20, 2001
    Date of Event
    February 13, 2001
    Report Date
    February 13, 2001
    Manufacturer
    STERI SYSTEMS CORP.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 2/27/01: THE MALFUNCTIONED DEVICE AS WELL AS NON-USED DEVICES (IN STOCK), WERE MADE AVAILABLE TO THE DIRECTOR OF MATERIALS MGMT DEPT FOR FORWARDING TO THE MFR FOR ENGINEERING REVIEW.

    Description of Event or Problem · 1

    SUCTION CAUTERY PENCIL (LOT 6003 PROD# 103-8575), WAS BEING USED ON ROUTINE TONSILECTOMY AND ADENOIDECTOMY. CAUTERY TIP IGNITIED W/FLAME. FLAME CONTINUED AFTER RELEASE OF FOOT PEDAL. CAUTERY WAS NOT IN CONTACT W/PATIENT, WHEN EQUIPMENT MALFUNCTIONED, BUT PT WAS ON OR TABLE. SMALL AMOUNT OF INSULATION MELTED ON TIP OF CAUTERY. CAUTERY TIP HAD NOT BEEN CLEANED OR MANIPULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6725 STERI-SYSTEMS CORPORATION SUCTION CAUTERY PENCIL GEI STERI SYSTEMS CORP. * 6003

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other