BEUDAMED
    FDA Adverse Event Other Summary report: N

    TLS3, 35C, THERMAL LIGATING SHEARS

    MDR report key: 1943809 · Received December 20, 2010

    Report

    Report Number
    2954339-2010-00027
    Event Type
    Other
    Date Received
    December 20, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 20, 2010
    Manufacturer
    STARION
    Product Code
    GEI
    PMA / PMN Number
    K062257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ASSOCIATED WITH STARION INSTRUMENTS (B)(4). THE THERMAL LIGATING SHEARS IN QUESTION WAS NOT RETURNED; THEREFORE, NO INVESTIGATION COULD BE CONDUCTED. NO PT INFO WAS PROVIDED.

    Description of Event or Problem · 1

    DURING A TOTAL COLECTOMY FOR CHROHN'S DISEASE, THE INSTRUMENT WORKED VERY WELL UNTIL THE INSULATION CAME OFF, AFTER MANY SEALS AND ABOUT ONE HOUR. THE INSTRUMENT WAS EXCHANGED WITH ANOTHER ONE AND USED FOR THE REMAINDER OF THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TLS3, 35C, THERMAL LIGATING SHEARS GEI ELECTROSURGICAL, CUTTING AND COAGULA GEI STARION 132-136D 001011

    Patients

    Seq Age Sex Outcome Treatment
    1