BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ MORCELLATOR

    MDR report key: 1621473 · Received February 18, 2010

    Report

    Report Number
    1621473
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 18, 2010
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    UNABLE TO PROPERLY CLEAN MORCELLATOR. AFTER MULTIPLE WASHINGS, BLOOD TINGED FLUID CONTINUES TO FLOW OUT OF DRILL.ABLE TO INSERT FINGERNAIL ALONG DRUM AND MORE FLUID FLOWS OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ MORCELLATOR ENDOSCOPIC, LAPAROSCOPE, GYNECOLOGIC, AND ACCESSORIES HET KARL STORZ ENDOSCOPY-AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *