BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINA BIPOLAR LOOP

    MDR report key: 3842815 · Received May 7, 2014

    Report

    Report Number
    3842815
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    LINA MEDICAL, INC.
    Product Code
    HIN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    CERAMIC INSULATED TIP OF LINA BIPOLAR LOOP DEVICE BROKE DURING THE PROCEDURE. IT WAS IMBEDDED IN THE SPECIMEN, REMOVED FROM THE PATIENT, AND HANDED OFF THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274948 LINA BIPOLAR LOOP COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) HIN LINA MEDICAL, INC. BL-200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR