BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOP TIP SURGICAL CAUTERY, STERILE, HIGH TEMPERATURE

    MDR report key: 503256 · Received December 24, 2003

    Report

    Report Number
    503256
    Event Type
    Other
    Date Received
    December 24, 2003
    Date of Event
    December 15, 2003
    Report Date
    December 17, 2003
    Manufacturer
    ABCO DEALERS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN IMPROPERLY DISCARDED HAND-HELD CAUTERY DEVICE STARTED A SMALL FIRE IN A SHARPS CONTAINER BUCKET. RESPONDING STAFF ACTIVATED THE FIRE ALARM, EVACUATED PTS PRESENT IN THE SMOKE COMPARTMENT AND EXTINGUISHED THE FIRE. NO PTS REQUIRED ANY TREATMENT RESULTING FROM THE INCIDENT, WHICH OCCURRED IN MINOR SURGERY. INVESTIGATION REVEALED THAT 4 CAUTERY UNITS WERE DISCARDED INTO THE SHARPS CONTAINER WITH THEIR TIPS INTACT AND WITHOUT THE PROTECTIVE COVER ON (CAP INSTRUCTIONS STATE "REPLACE CAP WHEN NOT IN USE. FOR SAFE DISPOSAL, BREAK OFF TIP WITH HEMOSTAT AND REPLACE COVER CAP. FAILURE TO FOLLOW THESE INSTRUCTIONS COULD RESULT IN FIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOP TIP SURGICAL CAUTERY, STERILE, HIGH TEMPERATURE HAND-HELD NOT CAUTERY GEI ABCO DEALERS, INC. UNK 0303-4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other