BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 2973924 · Received February 15, 2013

    Report

    Report Number
    1222780-2013-00030
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFORMATION. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) PRECAUTIONS: TO AVOID PERFORATION, KEEP THE DEVICE TIP UNDER DIRECT VISUALIZATION AND EXERCISE CARE AT ALL TIMES WHEN MANEUVERING IT OR CUTTING TISSUE CLOSE TO UTERINE WALL. NEVER USE THE DEVICE TIP AS A PROBE OR DISSECTING TOOL. (B)(4).

    Description of Event or Problem · 1

    A HYSTEROSCOPY WAS DONE PRIOR TO A MYOSURE TISSUE REMOVAL PROCEDURE. THE PHYSICIAN NOTED "A SMALL PATCH OF WHAT SHE THOUGHT WAS SCAR TISSUE AT THE FUNDUS AND WANTED TO ADDRESS IT WITH THE MYOSURE DEVICE." SHE INSERTED THE DEVICE AND APPROACHED THE PATCH OF TISSUE AND "THOUGHT SHE PERFORATED" AT THAT TIME. FLUID DEFICIT WAS INCREASING AND SHE DECIDED TO VIEW THE CAVITY VIA LAPAROSCOPE. A PERFORATION WAS SEEN AND CAUTERIZED (METHOD UNKNOWN). FOLLOWING A BRIEF RECOVERY PERIOD, THE PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69542 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA 12K29RB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MYOSURE HYSTEROSCOPE - SERIAL # UNK| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYS CTRL UNIT| SERIAL # UNK| SALINE DISTENTION MEDIA AQUILEX