BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX

    MDR report key: 1002045 · Received February 21, 2008

    Report

    Report Number
    MW5005625
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    June 1, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ARTHREX, INC
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING THE FOLLOWING PROCEDURE: LEFT KNEE DIAGNOSTIC ARTHROSCOPY, CHONDROPLASTY OF PATELLA, FEMORAL TROCHLEAR GROOVE, MEDIAL FEMORAL CONDYLE, LATERAL TIBIAL PLATEAU. DIFFUSE SYNOVECTOMY, OPEN EXCISION OF SUPERIOR PREPATELLAR BURSITIS, MINI-OPEN LATERAL RETINACULAR RELEASE. DURING THE MID PORTION OF THE SURGERY - THE SURGEON NOTED THAT ARTHROSCOPY PUMP WAS PUMPING VERY FAST AND WAS VERY AUDIBLE. THERE WAS NO SHAVING SUCTION BEING PERFORMED OR FLUID COMING OUT OF THE PORTALS. IT WAS THEN NOTED THAT THERE HAD BEEN A FAIRLY QUICK SUDDEN FLUID EXTRAVASATION INTO THE THIGH REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX CONTINUOUS WAVE III ARTHROSCOPY PUMP HRX ARTHREX, INC AR 6475 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization