BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYRUS ACMI

    MDR report key: 2894654 · Received March 26, 2008

    Report

    Report Number
    2894654
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    GYRUS ACMI
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTIVE VAGINAL HYSTERECTOMY ON (B)(6) 2008 USING THE PK GENERATOR WITH AN OPEN FORCEP. WHEN OPERATING ON THE PEDICLES, THE PK GENERATOR DID NOT SEEM TO OPERATE TO ITS FULL EXTENT. THERE WAS NO REAL DEFINITIVE WAY TO TELL IF THERE WAS ANY ELECTRICAL MALFUNCTION. HOWEVER, THERE WAS NO BLEEDING AT THE TIME AND ALL APPEARED TO BE COAGULATED. THE SURGERY PROCEEDED. THE PT DID WELL AND WAS TAKEN TO THE PACU AT 13:36 WITH THE ESTIMATED BLOOD LOSS AT THE TIME WAS 250 CC. THE PT BLOOD PRESSURE WAS LOW, BUT WAS TAKEN TO A HOSPITAL ROOM TO CONTINUE RECOVERY AT 15:50 WHEN HER CONDITION BEGAN TO DETERIORATE. SHE RETURNED TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY AT 19:05. DIAGNOSIS WAS ABDOMINAL HEMORRHAGING WITH AN ESTIMATED BLOOD LOSS OF 1500 CC. THREE UNITS OF PACKED RED CELLS WERE ADMINISTERED AND THE BLEEDING STOPPED. THE PT RETURNED TO THE PACU AT 22:00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS ACMI PK GENERATOR GEI GYRUS ACMI NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R