BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 3800263 · Received May 1, 2014

    Report

    Report Number
    1222780-2014-00069
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    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

    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, HYSTEROSCOPE AND AQUILEX SYSTEM 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 DURING A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL, THE PHYSICIAN WAS ABLE TO REMOVE APPROX 60% OF THE PATHOLOGY USING THE DISPOSABLE DEVICE WHEN THE FLUID DEFICIT REACHED 1000ML. THE PHYSICIAN USED GRASPERS TO REMOVE THE REMAINING PATHOLOGY. THE PHYSICIAN THEN PERFORMED A HYSTEROSCOPY AND "OBSERVED TISSUE GOLDEN IN COLOR" AND SUSPECTED A PERFORATION. IT IS UNK IF MEDICAL INTERVENTION WAS REQUIRED. ON (B)(6) 2014, IT WAS REPORTED THAT THE PATHOLOGY REPORT REVEALED SOME BOWEL TISSUE. THE PT'S BOWEL WAS SLIGHTLY PIERCED. THE PT WAS ADMITTED INTO THE HOSPITAL FOR TWO NIGHTS FOR OBSERVATION. IT IS UNK IF INTERVENTION WAS REQUIRED. THE PHYSICIAN REPORTED "THE PT IS DOING VERY WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261158 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM UTERINE TISSUE REMOVAL DEVICE HIH HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other AQUILEX FLUID SYSTEM - SERIAL # UNK| MYOSURE HYSTEROSCOPE - SERIAL# UNK| MYOSURE CONTROL UNIT - SERIAL# UNK