BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 483034 · Received September 11, 2003

    Report

    Report Number
    2210968-2003-00336
    Event Type
    Injury
    Date Received
    September 11, 2003
    Report Date
    August 20, 2003
    Manufacturer
    MEDSOURCE TECHNOLOGIES
    Product Code
    HFG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN OTHERWISE UNSPECIFIED LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, THE MD REPORTEDLY MORCELLATED THE LEFT EXTERNAL ILIAC ARTERY. IN RESPONSE, THE ARTERY WAS STENTED, THE ABDOMINAL INCISION WAS LEFT OPEN AND THE PT WAS EMERGENTLY FLOWN TO ANOTHER FACILITY FOR A VASCULAR REPAIR BY A CARDIOVASCULAR SURGEON. SUBSEQUENTLY, THE PT LOST THEIR PULSE IN THEIR LEFT LOWER EXTERMITY AND REQUIRED A SECOND SURGERY TO EXPLORE THE ARTERY AND EVACUATE CLOTS THAT HAD FORMED THERE (POSSIBLY AT THE SITE OF THE STENT). THEY THEN DEVELOPED A PELVIC HEMATOMA THAT RESOLVED ITSELF IN ABOUT EIGHT WEEKS AND ALSO EXPERIENCED SOME PERIOD OF PAIN FOLLOWING THE EVENT. THEY ARE REPORTEDLY DOING WELL TODAY AND HAVE FULLY RECOVERED. NO OTHER INFO IS AVAILABLE AT THIS TIME. THERE IS NO MENTION OF A MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR MORCELLATOR HFG MEDSOURCE TECHNOLOGIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention