BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLFE ARTHROSCOPY SCOPE

    MDR report key: 1432295 · Received August 1, 2009

    Report

    Report Number
    MW5012239
    Event Type
    Injury
    Date Received
    August 1, 2009
    Date of Event
    January 6, 2005
    Report Date
    August 1, 2009
    Manufacturer
    UNKNOWN
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM REPORTING ON MYSELF AS A PT - I AM AN ORTHOPEDIC SURGEON WHO HAD A ARTHROSCOPIC KNEE PARTIAL MENISECTOMY AT A FREE STANDING OUT PT SURGERY CENTER BY A VERY COMPETENT ORTHOPEDIC SURGEON. PAIN WAS OUT OF PROPORTION FOR THE NEXT WEEK POST OP WITH EFFUSION. ON POST OP CHECK AND ASPIRATION OF KNEE, I WAS FOUND TO HAVE STAPH EPI INFECTION IN KNEE WITH NO REASONABLE CAUSE-- I HAVE NO PREDISPOSING FACTORS AND AM VERY HEALTHY. I HAD SECOND SCOPE AND HOSPITALIZATION WITH IV ANTIBIOTICS FOLLOWED BY 6 WEEKS HOME INFUSION OF VANCOMYCIN FOR 6 WEEKS-- THIS STILL DID NOT ERADICATE INFECTION AND I HAD TO HAVE AN ARTHROTOMY TO CLEAN OUT KNEE. BY THIS TIME IT WAS TOO LATE AND MY KNEE WAS DESTROYED. I PUT UP WITH CHRONIC DAILY PAIN UNTIL I HAD A TOTAL KNEE REPLACEMENT IN 2008. THE ONLY POSSIBLE EXPLANTATION FROM MY SURGEON AND MYSELF WAS THAT AN IN COMPLETELY CLEANED SCOPE HAD BEEN PLACED INTO MY KNEE. WE WERE NOT ABLE TO PROVE THIS. NOW A REPORT IN MEDSCAPE IS WARNING INCOMPLETE CLEANING OF SCOPES RECOGNIZED AS CAUSING ISSUES. DOSE OR AMOUNT: NA, FREQUENCY: NA, ROUTE: INTRA-ARTIC. DATES OF USE: ONE HOUR 2005. DIAGNOSIS OR REASON FOR USE: TOM TREAT TORN MENISCUS OF KNEE. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOLFE ARTHROSCOPY SCOPE KNEE SCOPE HRX UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention