BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCIVOR MOUTH GAG FRAME

    MDR report key: 474110 · Received July 28, 2003

    Report

    Report Number
    474110
    Event Type
    Other
    Date Received
    July 28, 2003
    Date of Event
    May 1, 2003
    Report Date
    June 1, 2003
    Manufacturer
    PILLING SURGICAL
    Product Code
    KBN
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH OBSTRUCTIVE PALATINE TONSILS UNDERWENT A TONSILLECTOMY. A MCIVOR MOUTH GAG WAS PLACED, AND THE RIGHT TONSIL WAS REMOVED WITHOUT INCIDENT. BLEEDING WAS CONTROLLED WITH CAUTERY. THE IDENTICAL PROCEDURE WAS CARRIED OUT ON THE LEFT SIDE, AND ACCORDING TO THE OPERATIVE NOTE, A BURN WAS NOTICED TO THE LEFT ANTERIOR TONGUE THAT APPEARED TO HAVE OCCURRED BY TRANSDUCTION OF ELECTRICAL CURRENT THROUGH THE MOUTH GAG. THE BURNED AREA WAS APPROX 1 X 2CM IN DIMENSION BUT WAS VERY SUPERFICIAL. THE NON-VIABLE TISSUE WAS EXCISED AND THE WOUND WAS CLOSED WITH SUTURES. THE SURGEON BELIEVES THAT BETTER DESIGN OF THE INSTRUMENTS SO THAT THEY ARE INSULATED WOULD HAVE PREVENTED THIS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCIVOR MOUTH GAG FRAME MOUTH GAG FRAME KBN PILLING SURGICAL * *
    2 BLADES OTHER KBN PILLING SURGICAL * *
    3 SABRE 2400 BIPOLAR ESU GEI CONMED SABRE 2400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other ELECTROCAUTERY.