BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA COBLATOR II

    MDR report key: 7834126 · Received August 30, 2018

    Report

    Report Number
    1643264-2018-00643
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 3, 2018
    Report Date
    October 9, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GEI
    PMA / PMN Number
    K142999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. WE CANNOT DETERMINE IF THERE IS A RELATIONSHIP BETWEEN THE DEVICE AND THE INCIDENT BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. THERE ARE SEVERAL FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT SUCH AS THE RATE AND DEPTH OF TISSUE ABLATION WHICH IS AFFECTED BY THE SELECTED SET POINT, AMOUNT OF PRESSURE ON THE TISSUE, THE INTEGRITY OF THE ELECTRODE, AND THE SPEED WITH WHICH THE WAND IS PASSED OVER THE TARGET TISSUE. FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND IS MORE THAN LIKELY RELATED TO THE FAILURE IN THIS CASE IS THE CONTROLLER WHICH WAS NOT RETURNED FOR EVALUATION.B5: CORRECTED DATA. RELATED COMPLAINTS: C-0206275, C-0212090, C-0212091, C-0212106

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE SEEMS TO BE A TREND WITH THE WAND OF PERFORATION TONSULAR ARCHES. THERE WAS NO SIGNIFICANT DELAY AND A BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. FURTHER INFORMATION WAS REQUESTED IN ORDER TO CLARIFY HOW MANY CASES WERE INVOLVED, HOWEVER, THE SPECIFIC NUMBER IS UNKNOWN, THEREFORE A SECOND COMPLAINT WAS CREATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE SEEMS TO BE A TREND WITH THE WAND OF PERFORATION TONSULAR ARCHES. THERE WAS NO SIGNIFICANT DELAY AND A BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. FURTHER INFORMATION WAS REQUESTED IN ORDER TO CLARIFY HOW MANY CASES WERE INVOLVED, FOUR MORE CASES HAD THE SAME ISSUE WHICH ALL OF THEM ARE ALREADY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676469 EVAC 70 XTRA COBLATOR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other