BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ ROTOCUT MORCELLATOR

    MDR report key: 3976320 · Received June 18, 2014

    Report

    Report Number
    9610617-2014-00027
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 8, 2013
    Report Date
    June 9, 2014
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    GCJ
    PMA / PMN Number
    K061180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION IN THE SUMMONS THAT THE DEVICE MALFUNCTIONED.

    Description of Event or Problem · 1

    ALLEGEDLY, PER A SUMMONS RECEIVED BY KARL STORZ ENDOSCOPY-AMERICA, INC., THE PLAINTIFF UNDERWENT A SUPRA-CERVICAL HYSTERECTOMY PROCEDURE AT THE (B)(6), WHERE A KARL STORZ ROTOCUT MORCELLATOR WAS USED TO REMOVE THE PLAINTIFF'S UTERUS AND THE PLAINTIFF WAS DIAGNOSED WITH ENDOMETRIAL STROMAL SARCOMA AFTER THE SURGERY. ON(B)(6) 2013, SHE UNDERWENT A SECOND PROCEDURE AND HAS HAD 31 RADIATION TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357950 KARL STORZ ROTOCUT MORCELLATOR MORCELLATOR GCJ KARL STORZ GMBH & CO. 26713030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention