BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4153456 · Received October 8, 2014

    Report

    Report Number
    0001056128-2014-00119
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 15, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K133578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED. THEREFORE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. AS THE DEVICE WAS NOT RETURNED FOR INSPECTION, THE REPORTED ISSUE COULD NOT BE SUBSTANTIATED. FURTHERMORE, THE FACILITY¿S EQUIPMENT COULD NOT BE EVALUATED. AS THE GENERATOR WORKS TO POWER THE INSTRUMENT, ANY FAILURES OF THIS PIECE OF EQUIPMENT WILL RESULT IN THE INSTRUMENT NOT WORKING PROPERLY. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGASURE DEVICE WOULD NOT SEAL TISSUE PROPERLY DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631069 NA ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF1537 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1