BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4974951 · Received August 5, 2015

    Report

    Report Number
    0001056128-2015-00072
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    March 19, 2015
    Report Date
    June 15, 2015
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    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, AND EACH TIME THE MIN OR MAX BUTTON OR PEDAL WAS PRESSED THE DEVICE ACTIVATED AND AT NO TIME DURING TESTING DID THE DEVICE STOP WORKING OR EMIT ANY ADVERSE NOISE. THE DEVICE WAS EXAMINED FURTHER AND A BUILD UP OF DRIED 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 THAT AFTER TIGHTENING THE HAR36 ULTRASONIC SCALPEL, THE DEVICE WOULD NOT ROTATE. THE HANDPIECE WAS TIGHTENED NUMEROUS TIMES DURING THE CASE, AND THE GENERATOR KEPT ALARMING, "TIGHTEN ASSEMBLY" AND "REPLACE INSTRUMENT." 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
    515476 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HAR36 3408903

    Patients

    Seq Age Sex Outcome Treatment
    1