BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 9100782 · Received September 20, 2019

    Report

    Report Number
    0001056128-2019-00048
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    May 14, 2019
    Report Date
    September 20, 2019
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    UDI-DI
    07613327346251
    PMA / PMN Number
    K161693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. VISUAL INSPECTION REVEALED EVIDENCE OF CLINICAL USE. THE TIP OF THE DISTAL END OF THE BLADE WAS BROKEN OFF AND RETURNED WITH THE DEVICE. INSPECTION OF THE BROKEN BLADE COATING REVEALED SIGNS OF EROSION NEAR THE BLADE FRACTURE. THE TEFLON PAD AND CONTACT RINGS APPEAR TO BE INTACT. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE: JAWS/BLADE SUBASSEMBLY DAMAGE. INCIDENTAL AND PROLONGED ACTIVATION AGAINST SOLID SURFACES, SUCH AS BONE OR PLASTIC. THE INSTRUCTIONS FOR USE (IFU) STATE: USE THE TORQUE WRENCH (ALREADY MOUNTED TO THE SHAFT) TO TIGHTEN THE BLADE ONTO THE HAND PIECE. TURN THE TORQUE WRENCH CLOCKWISE WHILE HOLDING ONLY THE GRAY HAND PIECE UNTIL IT CLICKS TWICE INDICATING THAT SUFFICIENT TORQUE HAS BEEN APPLIED TO SECURE THE BLADE. DO NOT ATTEMPT TO BEND, SHARPEN, OR OTHER WISE ALTER THE SHAPE OF THE BLADE. DOING SO MAY CAUSE BLADE FAILURE AND USER OR PATIENT INJURY. AVOID CONTACT WITH ANY AND ALL OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES. NOTE: DO NOT USE ANY OTHER MEANS THAN THE TORQUE WRENCH TO ATTACH OR DETACH THE INSTRUMENT FROM THE HAND PIECE. NOTE: DO NOT TORQUE THE INSTRUMENT BY HAND WITHOUT THE TORQUE WRENCH OR DAMAGE MAY OCCUR TO THE HAND PIECE. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HARMONIC STOPPED WORKING DURING CASE WHILE IN USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894698 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HARH36 10047127 07613327346251

    Patients

    Seq Age Sex Outcome Treatment
    1