BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO2 ELECTRONIC INSUFFLATION SYSTEM

    MDR report key: 19701 · Received December 23, 1994

    Report

    Report Number
    19701
    Event Type
    Malfunction
    Date Received
    December 23, 1994
    Report Date
    December 22, 1994
    Manufacturer
    RICHARD-WOLF
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSUFFLATOR PURCHASED 6/94. PROBLEMS WERE IDENTIFIED BY PHYSICIANS STAFF WITH USE OF THE EQUIPMENT. FOR EXAMPLE, WHEN THE SMOKE EVACUATION WAS USED, THE ABDOMINAL PRESSURE COULD NOT BE MAINTAINED EVEN THOUGH THE GAUGES INDICATED THE SET PRESSURE. WITHOUT INFUSING THE SMOKE EVACUATOR, VISIBILITY WAS IMPAIRED. IN 9/94 THE SALES REP AND AN ENGINEER CAME TO THE HOSP TO INSERVICE THE STAFF ON USE OF THE EQUIPMENT. THEY FELT AFTER REVIEW THAT IT WAS A DESIGN PROBLEM, NOT A KNOWLEDGE PROBLEM. THEY PROMISED THAT A NEW UNIT WAS GOING TO BE APPROVED IN 12/94 BY FDA AND THEY WOULD EXCHANGE 2 UNITS FOR 2 NEW UNITS. 12/94 MANAGER OF SPECIAL SERVICES WAS CALLED REGARDING ABOVE, AND ONE UNIT WAS SENT BACK FOR EVALUATION PER HIS REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CO2 ELECTRONIC INSUFFLATION SYSTEM CO2 INSUFFLATOR FCX RICHARD-WOLF 2264-101

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other