BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPE TISSUE REMOVAL SYSTEM

    MDR report key: 2232592 · Received August 24, 2011

    Report

    Report Number
    1222780-2011-00167
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    DURING A MYOSURE PROCEDURE FOR INTRAUTERINE TISSUE REMOVAL AND A FLUID DEFICIT OF 7000CC WAS NOTED. "THE STORZ FLUID MANAGEMENT SYSTEM WAS USED WITH A FLUID PRESSURE OF APPROXIMATELY 100MM HG, FLOW RATE OF APPROXIMATELY 500CC PER MINUTE, AND VACUUM SETTING APPROXIMATELY 350." IT WAS REPORTED NO PERFORATION WAS FOUND AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVED LASIX (FUROSEMIDE) (DOSE AND ROUTE UNKNOWN) AND REMAINED IN THE HOSPITAL OVERNIGHT. SHE WAS DISCHARGED HOME THE NEXT DAY. ON (B)(6) 2011 THE PHYSICIAN REPORTED THE PATIENT IS DOING FINE.

    Devices

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

    Patients

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