BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 3070611 · Received April 12, 2013

    Report

    Report Number
    1222780-2013-00068
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) REVIEW WAS NOT ABLE TO BE CONDUCTED FOR THE MYOSURE SYSTEM AS PRODUCT IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. REFERENCE INTERNAL COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MYOSURE PROCEDURE FOR THE REMOVAL OF "A NUMBER OF LARGE FIBROIDS ...IN THE UTERINE CAVITY EQUALING FROM 2-4 CM" WAS COMPLETED IN 17 MINUTES. FOLLOWING THIS, IN SPITE OF A FLUID DEFICIT OF 1200CC AT END OF THIS PROCEDURE, THE PHYSICIAN INSERTED A RESECTOSCOPE AND "ATTEMPTED REPEATEDLY" TO REMOVE A LARGE FIBROID WHICH WAS FLOATING IN THE UTERINE CAVITY. THE FLUID DEFICIT CONTINUED TO MOUNT. FLUID MANAGEMENT INCLUDED ELEVATION OF THE SALINE BAGS, PRESSURE TO THE BAGS WITH A CUFF, AND THE NEPTUNE COLLECTION SYSTEM. THE PHYSICIAN EVENTUALLY ABORTED THIS ATTEMPT WHEN THE DEFICIT REACHED 4,450CC. THE PT'S FACE WAS "A LITTLE SWOLLEN" BUT HER VITAL SIGNS WERE STABLE. A CHEST X-RAY WAS NEGATIVE. IT WAS REPORTED THE PT RECEIVED LASIX (FUROSEMIDE) 10MG AND INTRAVENOUS (IV) ELECTROLYTES "DUE TO THE FLUID OVERLOAD." THE PHYSICIAN INSERTED A FOLEY CATHETER AND 800CC OF URINE DRAINED IMMEDIATELY. THE PT WAS ADMITTED TO THE HOSPITAL FOR OVER NIGHT OBSERVATION AND WAS DISCHARGED THE NEXT DAY. ON (B)(6) 2013, IT WAS REPORTED THAT THE PT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159764 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA UNK

    Patients

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