BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPE TISSUE REMOVAL SYSTEM

    MDR report key: 3212758 · Received July 1, 2013

    Report

    Report Number
    1222780-2013-00124
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 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

    SERIAL NUMBERS OF THE AQUILEX FLUID MANAGEMENT SYSTEM AND MYOSURE CONTROL UNIT WERE NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE DEVICE IS NOT BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER OF THE DISPOSABLE DEVICE. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WARNINGS: TO AVOID PERFORATION, KEEP THE DEVICE TIP UNDER DIRECT VISUALIZATION AND EXERCISE ARE AT ALL TIMES WHEN MANEUVERING IT OR CUTTING IT CLOSE TO THE UTERINE WALL. NEVER USE THE DEVICE TIP A PROBE OR DISSECTING TOOL. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) PRECAUTIONS: TO AVOID PERFORATION, DO NOT USE THE SCOPE TIP AS A PROBE AND EXERCISE CAUTION WHEN THE SCOPE IS BEING INSERTED THROUGH THE CERVIX AND WHEN THE SCOPE TIP IS NEAR THE UTERINE WALL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL, THE PHYSICIAN PERFORMED A SOUND (NOT HOLOGIC DEVICE). DURING THE MYOSURE PROCEDURE, THE FLUID DEFICIT SPIKED TO 1774ML (DISTENTION MEDIA WAS SALINE). THE PROCEDURE WAS COMPLETED. THE PHYSICIAN THEN PERFORMED A HYSTEROSCOPY AND NOTED A UTERINE PERFORATION. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297839 MYOSURE HYSTEROSCOPE TISSUE REMOVAL SYSTEM HIH HOLOGIC NA 13A22RA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CONTROL UNIT, UNK| MYOSURE HYSTEROSCOPE, 766245| AQUILEX FLUID MANAGEMENT SYSTEM, SERIAL # UNK| MYOSURE HYSTEROSCOPE TISSUE REMOVAL SYSTEM