BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 3926359 · Received July 2, 2014

    Report

    Report Number
    1222780-2014-00107
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED A MYOSURE FOR UTERINE TISSUE REMOVAL ON (B)(6) 2014. THE PHYSICIAN "CUT FOR 9 SECONDS WITH MINIMAL TISSUE OBTAINED." THE FLUID DEFICIT ROSE TO 2500 ML. THE PHYSICIAN BELIEVES HE PERFORATED AND ABORTED THE PROCEDURE. NO INTERVENTION WAS REQUIRED FOR THE PERFORATION AND FLUID WAS RETRIEVED. THE PATIENT WAS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386578 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM UTERINE TISSUE REMOVAL DEVICE HIH HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MYOSURE HYSTEROSCOPE, SERIAL # UNK| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM| CONTROL UNIT, SERIAL # UNK