BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION CAUTERY

    MDR report key: 10474 · Received December 13, 1993

    Report

    Report Number
    MW1000085
    Event Type
    Malfunction
    Date Received
    December 13, 1993
    Date of Event
    October 22, 1993
    Report Date
    December 6, 1993
    Manufacturer
    OLSEN ELECTROSURGICAL INSTRUMENTS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A TONSILECTOMY AND ADENOIDECTOMY USING THE SUCTION CAUTERY WITH THE SETTING OF 45 COAG, DR WAS BURNED. HE HAD USED THE CAUTERY PRIOR TO THIS INCIDENT. HE AGAIN USED THE CAUTERY ON THE SAME CASE AND WAS BURNED TWICE. THE SITE ON HIS THUMB WAS DEEPER THAN THE SECOND TIME HE WAS BURNED. THE BURN DID CAUSE A BIG BLISTER AND WAS REDDISH AROUND THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION CAUTERY CAUTERY GEI OLSEN ELECTROSURGICAL INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 * Other