BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAL LIGATING SHEARS

    MDR report key: 2241302 · Received August 19, 2011

    Report

    Report Number
    2954339-2011-00021
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 19, 2011
    Manufacturer
    STARION INSTRUMENTS
    Product Code
    GEI
    PMA / PMN Number
    K062257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TLS3 35C WAS RETURNED, DECONTAMINATED AND INVESTIGATED. A GENERAL INSPECTION OF THE RETURNED TLS3 35C WAS PERFORMED AND THERE WERE NO COSMETIC ISSUES. THE LEFT JAW BOOT WAS BROKEN AT THE TIP, CONFIRMING THE COMPLAINT. THE RIGHT HEAT SPREADER WAS BENT INWARDS. THE BOOT TEAR AND THE HEAT SPREADER BEING BENT INWARDS ARE CONSISTENT WITH THE JAWS NOT BEING COMPLETELY CLOSED WHEN INSERTING INTO THE CANNULA. INCOMPLETE CLOSURE DURING INSERTION OR REMOVAL FROM A CANNULA CAN CAUSE THE JAWS TO BE APART, FORCING THEM TO BE IN CONTACT WITH THE CANNULA; IF THIS OCCURS, THE BOOT OR OTHER COMPONENTS CAN GET DAMAGED. ALTHOUGH DEFINITIVE DAMAGE WAS FOUND, THE ROOT CAUSE COULD NOT BE DETERMINED. THERE HAS BEEN NO ADDITIONAL COMPLAINTS RECEIVED WITH HEAT SPREADERS BENT IN SUCH A MANNER.

    Description of Event or Problem · 1

    THE SURGEON ACTIVATED THE INSTRUMENT APPROXIMATELY 2 TIMES AND NOTICED A PIECE OF THE TIP BROKE OFF. THE SURGEON RETRIEVED THE PIECE. NO PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMAL LIGATING SHEARS TLS3 35C GEI STARION INSTRUMENTS 132-136D 908014

    Patients

    Seq Age Sex Outcome Treatment
    1