BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3771031 · Received April 24, 2014

    Report

    Report Number
    0001056128-2014-00050
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    December 4, 2013
    Report Date
    March 31, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K111600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, IT IS POSSIBLE THAT THE DEVICE WAS USED TO SEAL OVER METAL OBJECTS SUCH AS SUTURES, CLIPS AND/OR STAPLES OR APPROPRIATE BAR SETTING WERE NOT USED TO ACHIEVE THE DESIRED TISSUE EFFECT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. THE LOT CONTROL SHEET FOR THE COMPLAINT DEVICE INDICATES THAT THE DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THIS IS BEING FILED DUE TO THE DEVICE NOT COAGULATING BEING AN INHERENTLY DANGEROUS SITUATION EVEN THOUGH THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE LIGASURE DID NOT CAUTERIZE THE TISSUE PROPERLY." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROCEDURE DELAY. THERE WAS NO TREATMENT OR MEDICAL INTERVENTION REQUIRED AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249895 LIGASURE IMPACT ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200 2733297

    Patients

    Seq Age Sex Outcome Treatment
    1