BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE TISSUE REMOVAL DEVICE

    MDR report key: 2032285 · Received March 23, 2011

    Report

    Report Number
    3006659293-2011-00002
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 23, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    PMA / PMN Number
    K091100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FLUID INTRAVASATION EVENT WAS NOT DIRECTLY CAUSED BY THE MYOSURE DEVICE. BECAUSE A PRESSURE CUFF AND SALINE MEDIA WERE USED TO DISTEND THE UTERUS DURING THIS PROCEDURE, MANUAL CALCULATION OF THE FLUID DEFICIT BY THE NURSING STAFF WAS NECESSARY. FAILURE OF THE NURSING STAFF TO ACCURATELY CALCULATE AND TRACK THE FLUID DEFICIT WAS THE PROXIMATE CAUSE OF THIS FLUID INTRAVASATION EVENT. HOLOGIC IS TAKING A CONSERVATIVE APPROACH IN REPORTING THIS INCIDENT, DESPITE THE FACT THAT HOLOGIC'S MYOSURE DEVICE DID NOT DIRECTLY CAUSE THE EVENT.

    Description of Event or Problem · 1

    DURING A HYSTEROSCOPIC MYOMECTOMY WITH MYOSURE, SALINE AND A PRESSURE CUFF WERE USED TO DISTEND THE UTERUS. FIVE (5), 3 LITER BAGS OF SALINE WERE USED TO PERFORM THE CASE. NURSES MONITORED THE FLUID DEFICIT MANUALLY AND AT THE END OF THE PROCEDURE REPORTED THAT THEY HAD A DEFICIT OF 9000 CC. THE PATIENT WAS GIVEN LASIX (FUROSEMIDE) AND VOIDED 3,000 CC OF URINE PRIOR TO BEING TRANSPORTED TO A HOSPITAL FOR OVERNIGHT OBSERVATION. THE EXCESSIVE FLUID DEFICIT WAS ATTRIBUTED TO USER ERROR BY THE NURSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOSURE TISSUE REMOVAL DEVICE HYSTEROSCOPE & ACCESSORIES HIH HOLOGIC, INC. NA 101230-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R PRESSURE CUFF| SALINE DISTENSION MEDIA