BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 4102598 · Received September 12, 2014

    Report

    Report Number
    1222780-2014-00159
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K122498
    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 UNK. SERIAL NUMBER OF THE HYSTEROSCOPE 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 UNK. DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT ABLE TO BE CONDUCTED FOR THE MYOSURE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PHYSICIAN PERFORMED A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL ON (B)(6) 2014 AND THE FLUID DEFICIT STARTED TO INCREASE. THE PHYSICIAN REMOVED "70 PERCENT" OF THE FIBROID AND THE PATIENT WAS DISCHARGED HOME. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2014 WITH "ACTIVE BLEEDING" AND THE PATIENT WAS ADMITTED. THERE WAS NO INTERVENTION REQUIRED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565165 MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM UTERINE TISSUE REMOVAL DEVICE HIH HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization MYOSURE CONTROL UNIT: H1803G13D0| MYOSURE HYSTEROSCOPE: SERIAL NO.- UNK