BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4916494 · Received July 15, 2015

    Report

    Report Number
    0001056128-2015-00055
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K133672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. INSPECTION OF THE RETURNED DEVICE REVEALED EVIDENCE OF CLINICAL USE INCLUDING BIOLOGICAL MATERIAL ON THE DISTAL TIP AND AN INDENTION IN THE TEFLON PAD. THE SHAFT ROTATION AND THE JAW ACTUATION OF THE DEVICE WERE FOUND TO BE ACCEPTABLE. THE DEVICE WAS CONNECTED TO A GENERATOR AND FAILED WITH TWO "TIGHTEN ASSEMBLY" ERRORS (AFTER WHICH THE ASSEMBLY WAS TIGHTENED) AND A "REPLACE INSTRUMENT" ERROR. THE DEVICE WAS EXAMINED FURTHER AND A BUILD UP OF TISSUE/FLUID WAS NOTICED ALONG THE ROD WHICH CAN DISRUPT HARMONIC FREQUENCY AND REDUCE CUTTING ABILITY. THE ROD WAS INSPECTED FOR FRACTURES, AND NONE WERE FOUND. THE DISTAL GASKET ON THE ROD WAS EXAMINED AND REVEALED SIGNS OF DAMAGE AND WEARING OF THE GASKET LIP WHICH WOULD ALLOW FLUID/TISSUE TO RISE UP THE ROD. THE CAUSE OF TISSUE/FLUID BUILD UP IS DAMAGE TO THE DISTAL GASKET; ACTION IS BEING TAKEN TO ADDRESS THIS ISSUE. TISSUE BUILD UP DUE TO DISTAL GASKET DAMAGE CAN DISRUPT HARMONIC FREQUENCY AND POTENTIALLY REDUCE CUTTING ABILITY; THEREFORE, THE REPORTED COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE GENERATOR FOR THE HAR36 ULTRASONIC SCALPEL SAID 'NOT FULLY TIGHTENED'. THE FACILITY TIGHTENED THE DEVICE AND TRIED A DIFFERENT GENERATOR; HOWEVER, IT OCCURRED AGAIN. THE DEVICE ALSO HISSED WHEN ACTIVATED. THERE WAS NO MEDICAL INTERVENTION, SURGICAL DELAY, OR ADVERSE CONSEQUENCES REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461127 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HAR36 3441901

    Patients

    Seq Age Sex Outcome Treatment
    1