BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 3212734 · Received June 28, 2013

    Report

    Report Number
    1222780-2013-00116
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE DISPOSABLE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE CONDUCTED FOR THE MYOSURE SYSTEM AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WARNINGS: TO AVOID PERFORATION, KEEP THE DEVICE TIP UNDER DIRECT VISUALIZATION AND EXERCISE CARE AT ALL TIMES WHEN MANEUVERING IT OR CUTTING IT CLOSE TO THE UTERINE WALL. NEVER USE THE DEVICE TIP AS 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

    PRIOR TO A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL THE PHYSICIAN PERFORMED A SOUNDING (NOT A HOLOGIC DEVICE). DURING A MYOSURE PROCEDURE THE PATIENT HAD A FLUID DEFICIT OF 1200ML (DISTENTION MEDIA WAS SALINE). THE PHYSICIAN THEN PERFORMED A HYSTEROSCOPY AND VISUALIZED A PERFORATION AT THE PATIENT'S "LEFT OSTIA". THE PROCEDURE WAS COMPLETED. THERE WAS NO INTERVENTION REQUIRED FOR THE FLUID DEFICIT AND PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295298 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other AQUELEX FLUID MNG SYSTEM,SERIAL NUMBER - (B)(4)| MOYSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM| CONTROL UNIT - SERIAL NUMBER UNK| MYOSURE HYSTEROSCOPE, SERIAL NUMBER - UNK