BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCISE LAPAROSCOPIC MORCELLATOR

    MDR report key: 2953981 · Received January 17, 2013

    Report

    Report Number
    2953981
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    September 12, 2012
    Report Date
    January 17, 2013
    Manufacturer
    LINA MEDICAL, INC
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SURGEON NOTED THAT THE LAPAROSCOPIC MORCELLATOR TRIGGER STUCK AND THE MORCELLATOR STOPPED ROTATING/WORKING. THE DEVICE WAS REMOVED FROM THE FIELD, AND A NEW DEVICE WAS UTILIZED WITHOUT ISSUE. IT IS UNKNOWN IF THE NEW DEVICE WAS OF THE SAME OR A DIFFERENT LOT. THERE WERE NOT ADVERSE AFFECTS TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY WITH DIAGNOSTIC CYSTOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25497 XCISE LAPAROSCOPIC MORCELLATOR LAPAROSCOPIC, GYNECOLOGIC, ACCESSORY HET LINA MEDICAL, INC * 11394

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR