BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE

    MDR report key: 272767 · Received April 10, 2000

    Report

    Report Number
    272767
    Event Type
    Injury
    Date Received
    April 10, 2000
    Date of Event
    March 9, 2000
    Report Date
    March 13, 2000
    Manufacturer
    GYNECARE
    Product Code
    HFG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 03/09/2000, PT WAS UNDERGOING LAPAROSCOPY AND HYSTEROSCOPY WITH MYOMECTOMY FOR UTERINE FIBROIDS. ONCE THE FIBROIDS WERE CAUTERIZED AND RESECTED, THE MORCELLATOR WAS INSERTED. THE FIRST LARGE FIBROID WAS MORSELIZED AND REMOVED. DURING THE PROCESS OF MORSELIZING THE SECOND FIBROID, THE DESCENDING COLON WAS PUNCTURED. THE ABDOMEN WAS OPENED AND HEMATOMA WAS EVACUATED. A 1.0-1.5CM PERFORATION AT THE ANTIMESENTERIC BORDER OF THE SIGMOID COLON WAS IDENTIFIED. GENERAL SURGEONS WERE CONSULTED AND THE PERFORATION WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE LAPAROSCOPIC MORCELLATOR HFG GYNECARE TA190900 052699

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R