BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERI SYSTEMS CORPORATION

    MDR report key: 316908 · Received February 19, 2001

    Report

    Report Number
    MW1021123
    Event Type
    Other
    Date Received
    February 19, 2001
    Date of Event
    February 15, 2001
    Report Date
    February 15, 2001
    Manufacturer
    STERI-SYSTEMS CORP
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ON OR TABLE FOR TONSILECTOMY AND ADENOIDECTOMY WITH SUCTION CAUTERY IN USE. SURGEON STATED FLAME/FLASH NOTED ON TIP OF SUCTION CAUTERY. CAUTERY WAS NOT IN CONTACT WITH PT WHEN FLAME NOTED. SMALL AMOUNT OF TEFLON OR PROTECTIVE COATING MELTED ON END OF SUCTION CAUTERY. NO ADVERSE REACTIONS NOTED. CAUTERY REMOVED FROM STERILE FIELD OR REPLACED WITH NEW ONE - NO PROBLEMS NOTED. SUCTION CAUTERY HAD NOT BEEN CLEANED OR MANIPULATED PRIOR TO INCIDENT. BIRTCHER-BOVIE UNIT REMOVED FROM ROOM AND SENT FOR INSPECTION (TO CLINICAL ENGINEERING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6434 STERI SYSTEMS CORPORATION SUCTION CAUTERY PENCIL GEI STERI-SYSTEMS CORP PROD # 103-8575 1194

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other