BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 5095961 · Received September 22, 2015

    Report

    Report Number
    0001056128-2015-00082
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K133672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION; IT WAS DISCARDED BY THE FACILITY. AS THE DEVICE REPORTEDLY EMITTED A HISSING NOISE, WHICH IS INDICATIVE OF TISSUE/FLUID BUILD UP PAST THE DISTAL GASKET, A MALFUNCTION MDR IS BEING FILED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE HAR36 ULTRASONIC SCALPEL HAD A "RELEASE PRESSURE ON JAWS" ERROR CODE AND WAS MAKING A HISSING NOISE. THERE WAS NO MEDICAL INTERVENTION OR SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625060 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HAR36 3792001

    Patients

    Seq Age Sex Outcome Treatment
    1