BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 5109435 · Received September 28, 2015

    Report

    Report Number
    0001056128-2015-00088
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 21, 2015
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K133672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 EXCESSIVE BIOLOGICAL MATERIAL ON THE DISTAL TIP AND AN INDENTION IN THE TEFLON PAD. DURING INVESTIGATION, 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. TISSUE BUILD UP DUE TO DISTAL GASKET DAMAGE CAN DISRUPT HARMONIC FREQUENCY AND POTENTIALLY REDUCE CUTTING ABILITY. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HAR36 DEVICE HAD EITHER INTERMITTENT SIGNALS, FALSE ALARMS, OR SHUT OFF. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640509 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HAR36 3782097

    Patients

    Seq Age Sex Outcome Treatment
    1