BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSTEM 83 PLUS

    MDR report key: 2012649 · Received February 28, 2011

    Report

    Report Number
    2523209-2011-00001
    Event Type
    Other
    Date Received
    February 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 28, 2011
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FLG
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS SCOPE WAS WASHED AND HIGH LEVEL DISINFECTED USING SYSTEM 83. SCOPE WAS THEN PLACED IN CABINET FOR STORAGE AND SCOPE WAS FOUND TO BE LEAKING FLUID. SERVICE TECH, WAS IMMEDIATELY DISPATCHED TO HOSPITAL FOR EVAL AND SERVICE. CUSTOM TECHNICIAN PERFORMED A COMPLETE SERVICE ON MACHINE, TECHNICIAN ALSO OBSERVED THAT THE FACILITY WAS IMPROPERLY ATTACHING SCOPE(S) TO THE SYSTEM 83 AND A TRAINING WAS RE-PERFORMED ONSITE. WITH VERIFICATION THAT SYSTEM WAS WORKING PROPERLY AND HAD STAFF MEMBERS SIGN OFF AFTER RETRAINING WAS COMPLETED.

    Description of Event or Problem · 1

    SCOPE WAS FOUND IN STORAGE CABINET LEAKING FLUID ON 1 OLYMPUS SCOPE, BEING SETUP FOR A CASE. NO PRIOR PROCEDURES WERE DONE USING THE INDENTED SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 83 PLUS AUTOMATED ENDOSCOPE REPROCESSOR FLG CUSTOM ULTRASONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1