BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE

    MDR report key: 1100125 · Received August 5, 2008

    Report

    Report Number
    1717344-2008-00352
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 10, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT : 08/05/2008. COVIDIEN LP (FORMERLY VALLEYLAB) HAS INVESTIGATED REPORTS OF THE BLUE INSULATION MELTING ON THE PRECISE LS1200. ANALYSIS OF RETURNED PRODUCTS SHOWS THAT ALTHOUGH THERE CAN BE SOME DEGRADATION OF THE COATING, IN MOST CASES THIS DOES NOT HAVE A NEGATIVE CLINICAL OR SAFETY OUTCOME. THE INSTRUCTIONS FOR USE HAVE BEEN MODIFIED TO ADD A CAUTION INDICATING THAT THE LS1200 SHOULD NOT BE USED AS BIPOLAR SCISSORS. ALTHOUGH THE REPORTED INJURY RATE FOR THIS ISSUE IS VERY LOW, A PROJECT IS UNDERWAY TO INVESTIGATE A MORE ROBUST COATING MATERIAL. REPORTED INJURIES HAVE BEEN MINOR IN NATURE WITHOUT SERIOUS EFFECT TO THE PATIENT. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING AN INFILTRATING LIPOMA PROCEDURE, THE INSULATING LAYER ON THE TOP OF THE JAWS, SHRIVELED UP AND DETACHED IN PART INTO THE PATIENT CAVITY. THEY RETRIEVED THE PART FROM THE PATIENT CAVITY. THEY THEN CHANGED TO A NEW DEVICE AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE PRECISE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 138735

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR