BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLORADO TIP

    MDR report key: 545049 · Received February 9, 2004

    Report

    Report Number
    545049
    Event Type
    Injury
    Date Received
    February 9, 2004
    Date of Event
    October 14, 2003
    Report Date
    February 9, 2004
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY FOLLOWING A BILATERAL BREAST REDUCTION, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED SWELLING ON THE RIGHT SIDE, AFTER THE DRESSINGS WERE APPLIED. THE PATIENT HAD BEEN EXTUBATED BUT NOT MOVED OFF THE OPERATING ROOM TABLE. PT WAS RE-INTUBATED. THE SUTURES FROM THE RIGHT BREAST WERE REMOVED. PT HAD A BLOOD CLOT BOTH MEDIALLY AND LATERALLY THAT WAS ABOUT 250 CC. IT WAS THOROUGHLY IRRIGATED, BUT NO SOURCE OF BLEEDING WAS FOUND. THERE WERE A FEW TINY OOZING VESSELS BUT NOTHING MAJOR. NO SIGNIFICANT-SIZED VESSELS WERE BLEEDING OR OOZING. AFTER CAREFUL IRRIGATION, A THOROUGH CHECK WAS MADE FOR ANY BLEEDERS -AND THERE WERE NONE. THE WOUND WAS RE-CLOSED. THE PATIENT WAS DISCHARGED THE FOLLOWING MORNING WITHOUT FURTHER PROBLEM.IT WASN'T UNTIL THERE WERE TWO MORE CASES SIMILAR TO THIS ONE THAT USE OF THE COLORADO TIP WAS IDENTIFIED, THROUGH A ROOT CAUSE ANALYSIS, AS THE POSSIBLE COMMON CAUSE; THE SURGEON HAD ONLY RECENTLY BEGUN TO USE THIS PARTICULAR DEVICE FOR THIS PROCEDURE. (BOTH OF THE OTHER CASES ARE ALSO BEING REPORTED TO MEDSUN.) THE SAME SURGEON WAS INVOLVED IN ALL 3 EVENTS. IT IS UNKNOWN IF THE SURGEON WAS USING THE DEVICE DIFERENT FROM WHAT IS RECOMMENDED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, THEY WERE UNAWARE OF THE POSSIBLE LINK BETWEEN THE 3 CASES FOR ALMOST 3 MONTHS AFTER THE LAST ONE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO TIP ESU TIP GEI MEGADYNE MEDICAL PRODUCTS INC. NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R NO OTHER THERAPIES