BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMALL EAGLE GRAVITY STERILIZER

    MDR report key: 187250 · Received September 9, 1998

    Report

    Report Number
    2515984-1998-00004
    Event Type
    Other
    Date Received
    September 9, 1998
    Date of Event
    August 18, 1998
    Report Date
    August 19, 1998
    Manufacturer
    STERIS CORP.
    Product Code
    FLE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 08/18/1998, SIXTEEN (16) MICROSCOPIC OPERATIONS WERE PERFORMED USING INSTRUMENTS STERILIZED IN STERIS' EAGLE 2000 STERILIZER. WHILE PERFORMING ONE OF THOSE OPERATIONS, THE SURGEON NOTICED MICROSCOPIC SIZE BLACK PARTICLES IN THE INCISION. THESE PARTICLES WERE SPONGED FROM THE INCISION, AND THE OPERATION PROCEEDED NORMALLY. NO POST OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. THE SURGEON, FELT THAT THE STERILIZER WAS THE SOURCE OF THE SMALL BLACK PARTICLES DEPOSITED INTO THE INCISION DURING SURGERY. HE BELIEVES THE PARTICLES WERE ON THE INSTRUMENTS AFTER BEING STERILIZED. THIS MED WATCH REPORT IS SUBMITTED DUE TO THE ALLEGATION THAT CO'S DEVICE CONTRIBUTED TO A POTENTIAL MEDICAL PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL EAGLE GRAVITY STERILIZER STEAM STERILIZER FLE STERIS CORP. 2011 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other