BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 2221243 · Received August 16, 2011

    Report

    Report Number
    1222780-2011-00149
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE MYOSURE CONTROL UNIT AND HYSTEROSCOPE NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE DEVICE IS NOT BEING RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEWS WERE NOT ABLE TO BE CONDUCTED FOR THE MYOSURE SYSTEM AS PRODUCT IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE MYOSURE SYSTEM. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED OR DEVICE EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    DURING A REPORTED 1.5 HOUR MYOSURE PROCEDURE FOR THE REMOVAL OF A 5CM CALCIFIED FIBROID IN THE LEFT ANTERIOR WALL OF THE UTERUS, A PATIENT DEVELOPED A FLUID DEFICIT OF 3750CC. THE PROCEDURE WAS ABORTED. SEVEN BAGS OF SALINE WERE USED ON A "STRYKER PUMP" THE "FLUID PRESSURE WAS 89-95 AND FLOW RATE 100. THE VACUUM SETTING WAS 300-400HG." NO DIAGNOSTIC HYSTEROSCOPY WAS DONE AFTER ABORTING THE PROCEDURE BECAUSE VISUALIZATION WAS POOR. LASIX (FUROSEMIDE) "40CC WAS GIVE IN THE OR [OPERATING ROOM]." THE PATIENT "IMMEDIATELY STARTED URINATING AND THE RN (REGISTERED NURSE) STAFF NOTED THE PATIENT WAS DOING FINE." THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R MYOSURE HYSTEROSCOPE: SERIAL NUMBER UNKNOWN| CONTROL UNIT: SERIAL NUMBER UNKNOWN| STRYKER PUMP| SALINE - DISTENTION MEDIA.| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM