BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 2253951 · Received September 14, 2011

    Report

    Report Number
    1222780-2011-00172
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    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

    SERIAL NUMBER OF THE MYOSURE CONTROL UNIT AND HYSTEROSCOPE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE HAS BEEN SEQUESTERED AT THE FACILITY THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THE DEVICE IS REC'D AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    DURING A MYOSURE PROCEDURE FOR INTRAUTERINE TISSUE REMOVAL OF A 7 TO 8CM FIBROID THE PHYSICIAN SAW "LITTLE SHARDS OF THE (B)(4) SHAFT BEING CUT OUT BY THE MYOSURE BLADE." THE PROCEDURE WAS ABANDONED AND THE PHYSICIAN "IRRIGATED THE CAVITY WITH SALINE TRYING TO RECOVER ALL THE PIECES OF THE METAL." THE PT WAS DISCHARGED HOME AFTER A BRIEF RECOVERY PERIOD. ON (B)(6) 2011, THE PHYSICIAN REPORTED THE PT WAS SEEN ON F/U AND "IS DOING FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA 110531-2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MYOSURE HYSTEROSCOPE - SERIAL NUMBER UNK| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM| PRESSURE CUFF| CONTROL UNIT- SERIAL NUMBER UNK| SALINE DISTENTION MEDIA