BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 257735 · Received January 6, 2000

    Report

    Report Number
    1030322-1999-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2000
    Date of Event
    December 7, 1999
    Report Date
    January 5, 2000
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING EYE SURGERY CAUTERY HAD BEEN USED AND THEN PLACED ON A STACK OF 4X4'S. THE CAUTERY WAS THEN NOTED TO BE ON (END WAS RED), NO ONE WAS TOUCHING IT. IT HAD NOT SHUT OFF AUTOMATICALLY. IT WAS THEN NOTED THAT THE 4X4'S WERE STARTING TO FLAME. THEY WERE DOUSED WITH WATER WITHOUT FURTHER INCIDENT. THE TECH HAD TO PRESS THE BUTTON SEVERAL TIMES BEFORE THE CAUTERY TURNED OFF. THE PT WAS NOT HARMED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BATTERY OPERATED CAUTERY GEI AARON MEDICAL INDUSTRIES * 0699B

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other