BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM ULTRASONIC SCOPE WASHING MACHINE

    MDR report key: 509082 · Received January 20, 2004

    Report

    Report Number
    MW1030896
    Event Type
    Injury
    Date Received
    January 20, 2004
    Date of Event
    December 8, 2003
    Report Date
    January 9, 2004
    Manufacturer
    CUSTOM ULTRASONIC, INC.
    Product Code
    FEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FLEXIBLE SIGMOIDOSCOPE DID NOT COMPLETE HIGH LEVEL DISINFECTION CYCLE PRIOR TO USE ON ANOTHER PT. LID BUMPER DETACHED FROM CUSTOM-ULTRASONIC AND LODGED INTO CIDEX PUMP AND OBSTRUCTED IN-FLOW OF CIDEX INTO BAY WITH SCOPE CAUSING A COMPLETED RINSE CYCLE BUT NOT A HIGH LEVEL DISINFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONIC SCOPE WASHING MACHINE STERILIZER- ELECTRIC FEB CUSTOM ULTRASONIC, INC. SYSTEM83 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention