BEUDAMED
    FDA Adverse Event Summary report: N

    RUHOF ENDOZIME

    MDR report key: 1869089 · Received October 12, 2010

    Report

    Report Number
    1869089
    Date Received
    October 12, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 12, 2010
    Manufacturer
    THE RUHOF CORPORATION
    Product Code
    GDY
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ALL SURGERIES AT THE AMBULATORY SURGERY CENTER WERE STOPPED UNTIL THE CULTURES RESULTS WERE BACK AND THE INVESTIGATION WAS CONCLUDED. ALL SCOPES WERE SENT BACK TO THE MANUFACTURER FOR INSPECTION. DISCONTINUED USE OF RUHOF ENDOZIME SPONGES.ALL INFECTED PATIENTS WERE REFERRED TO EPIDEMIOLOGIST FOR TREATMENT. ALL PHYSICIANS WHO HAD DONE SURGERY WITHIN 30 DAYS OF EVENT WERE NOTIFIED AND EACH PATIENT'S RECORDS WERE REVIEWED. NO OTHER REPORTS OF POST OP INFECTION WITH PSEUDOMONAS AERUGINOSA.THE CENTRAL SERVICE EMPLOYEES WERE ALL EXPERIENCED IN CLEANING AND STERILIZING INSTRUMENTS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE PREPACKAGED DISPOSABLE RUHOF ENDOZIME SPONGES WAS CONTAMINATED WITH PSEUDOMONAS AERUGINOSA ORGANISM AT SOME TIME PRIOR TO PACKAGING AND BEING SHIPPED TO FACILITIES. THE SCOPES WERE CONTAMINATED BY THE USE OF THE SPONGE DURING THE INITIAL CLEANING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUHOF ENDOZIME ENDOZIME SPONGE GDY THE RUHOF CORPORATION * B7983

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NO OTHER THERAPIES
    2 31 YR
    3 62 YR
    4 56 YR