BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUCLEAR OPERATIVE HYSTEROSCOPE 8.0

    MDR report key: 4890102 · Received July 4, 2015

    Report

    Report Number
    3003604053-2015-00054
    Event Type
    Injury
    Date Received
    July 4, 2015
    Date of Event
    April 24, 2013
    Report Date
    June 3, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HIH
    PMA / PMN Number
    K013870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: LITERATURE CITATION: BLIKKENDALL, MATHIJS D., TJALINA W. O. HAMERLYNCK, MIRIAM M. F. HANSTEDE, FRANK WILEM JANSEN, BENEDICTUS C. SCHOOT (2013). AN ALTERNATIVE APPROACH FOR REMOVAL OF PLACENTAL REMNANTS: HYSTEROSCOPIC MORCELLATION. THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2013) 20, 796-802. (B)(4).

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW THE FOLLOWING INFORMATION WAS PRESENTED: DURING A HYSTEROSCOPIC PROCEDURE USING A TRUCLEAR OPERATIVE HYSTEROSCOPE 8.0 TO REMOVE PLACENTAL REMNANTS THE PATIENT EXPERIENCED HEMORRHAGE WHICH RESULTED IN A D & C, ONE WEEK AFTER INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434164 TRUCLEAR OPERATIVE HYSTEROSCOPE 8.0 HYSTEROSCOPE AD ACCESSORIES HIH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention