BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4940274 · Received July 24, 2015

    Report

    Report Number
    0001056128-2015-00068
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    January 13, 2015
    Report Date
    June 15, 2015
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K133672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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 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 GENERATOR AND PASSED THE INITIAL TESTING. THE FOOT PEDALS AND MIN BUTTON WERE ABLE TO ACTIVATE THE DEVICE, BUT THE MAX BUTTON WOULD NOT ACTIVATE THE DEVICE. THE DEVICE WAS ABLE TO SUCCESSFULLY ACTIVATE WITH THE FOOT PEDALS AND MIN BUTTON, AND AT NO TIME DID THE DEVICE FAIL TO ACTIVATE OR STOP WORKING, PRODUCE AN ERROR CODE OR EMIT ANY ADVERSE NOISE. THE MEMBRANE SWITCH ASSEMBLY (MSA) WAS TESTED, AND THE MAX BUTTON FAILED. INSPECTION OF THE MSA REVEALED SIGNS OF DRIED FLUID IN THE HANDLE AND UNDERNEATH THE MAX BUTTON PAD. THE DEVICE WAS EXAMINED FURTHER AND A BUILD UP OF TISSUE/FLUID WAS NOTICED ALONG THE ROD. 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 TO RISE UP THE ROD INTO THE HANDLE. 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 THAT THE GENERATOR FOR THE HAR36 ULTRASONIC SCALPEL DISPLAYED A REACTIVATE ERROR MESSAGE. THE DEVICE WAS RETESTED NUMEROUS TIMES BUT WOULD NOT PASS TESTING. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES REPORTED. SURGICAL DELAY WAS MINIMAL TO REPLACE THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484034 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS HAR36 3332951

    Patients

    Seq Age Sex Outcome Treatment
    1