BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED ESU HANDPIECE CAT # 130307

    MDR report key: 110856 · Received August 6, 1997

    Report

    Report Number
    110856
    Event Type
    Malfunction
    Date Received
    August 6, 1997
    Date of Event
    May 12, 1997
    Report Date
    May 12, 1997
    Manufacturer
    CONMED CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE TO EXCISE THE FAT PAD FROM THE INNER SURFACE OF THE LEFT LOWER EYELID, A SPARK FROM THE CAUTERY IGNITED THE LEFT UPPER EYELASHES. NASAL O2 WAS IN USE UNDER THE OPTHALDRAPE DURING THE PROCEDURE. SPOKE WITH DOCTOR, ON 5/14/97. THERE WERE NO ADVERSE EFFECTS FROM THE INCIDENT, AND NO FURTHER ACTION OR TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ESU HANDPIECE CAT # 130307 HAND CONTROL PENCIL LOT # J97070 GEI CONMED CORP. * J97070

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other