BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 6351295 · Received February 22, 2017

    Report

    Report Number
    0001056128-2017-00039
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    December 2, 2016
    Report Date
    February 22, 2017
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    UDI-DI
    00885825016012
    PMA / PMN Number
    K100537
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. IT WAS STATED THE DEVICE WAS DISCARDED AT THE USER FACILITY. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, INSPECTION/TESTING WAS UNABLE TO BE PERFORMED. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER AND/OR SERIAL NUMBER WAS NOT REPORTED. ALL STRYKER SUSTAINABILITY SOLUTIONS REPROCESSED DEVICES ARE SOLD AS STERILE AND ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL IN ACCORDANCE TO APPLICABLE ISO STANDARDS. WHEN THE STERILE BARRIER OF ANY DEVICE IS OPENED, THE STERILITY OF THAT DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND THE CONTROL OF STRYKER SUSTAINABILITY SOLUTIONS. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE DEVICE MISHANDLING DURING PREPARATION PRIOR TO PROCEDURE CAUSING CONTAMINATION OF NON-BIOLOGICAL PARTICLES/DEBRIS ON THE DEVICE AND/OR NON-STERILE TECHNIQUES USED. THE INSTRUCTIONS FOR USE (IFU) STATE: WARNINGS AND PRECAUTIONS: - THE USE OF THESE INSTRUMENTS REQUIRES A THOROUGH UNDERSTANDING OF THE TECHNIQUES AND PRINCIPLES OF LASER, ELECTROSURGICAL, AND ULTRASONIC PROCEDURES. INAPPROPRIATE USE MAY RESULT IN SHOCK AND BURN HAZARDS TO BOTH PATIENT AND MEDICAL PERSONNEL OR DAMAGE TO THE DEVICE OR OTHER MEDICAL INSTRUMENTS. CHECK AND ENSURE ELECTRICAL INSULATION OR GROUNDING IS NOT COMPROMISED. DO NOT IMMERSE INSTRUMENTS IN LIQUID UNLESS IT IS DESIGNED AND STATED. - HIGH TEMPERATURES AT THE DISTAL END OF THE SHAFT CAN OCCUR DUE TO BLOOD AND TISSUE BUILDUP BETWEEN THE BLADE AND SHAFT. REMOVE ANY VISIBLE TISSUE TO PREVENT BURN INJURY. - AVOID INCIDENTAL AND PROLONGED ACTIVATION AGAINST SOLID SURFACES (SUCH AS BONE), WHICH MAY RESULT IN BLADE HEATING AND/OR BLADE FAILURE. - WHEN THE INSTRUMENT BLADE IS ACTIVATED THE BLADE TIP IS ACTIVE AND WILL CUT AND COAGULATE TISSUE. CARE MUST BE TAKEN TO AVOID UNINTENTIONAL CONTACT BETWEEN THE BLADE SURFACES AND SURROUNDING TISSUES. -VERIFY HEMOSTASIS AFTER WITHDRAWING INSTRUMENT. IF BLEEDING IS STILL OBSERVED, EMPLOY APPROPRIATE TECHNIQUES TO ACHIEVE HEMOSTASIS. ASSEMBLY: - REMOVE THE INSTRUMENT FROM THE PACKAGE AND PLACE IT IN A STERILE WORK AREA USING ASEPTIC TECHNIQUE. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HARMONIC FOCUS WAS USED DURING A HEMITHYROIDECTOMY. THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND UPON DISCHARGE THE PATIENT WAS NOT PRESCRIBED ANTIBIOTICS. FIVE DAYS POST-PROCEDURE THE PATIENT DEVELOPED AN INFECTION AND WAS ADMITTED WITH A LARGE ABSCESS AT THE SURGICAL SITE WHICH REQUIRED IMMEDIATE INCISION AND DRAINAGE. THE PATIENT SPENT TIME INTUBATED IN CRITICAL CARE AND EXPERIENCED JAW PROBLEMS THAT SHE RELATES TO BEING INTUBATED FOR SEVERAL DAYS. THERE WAS NO PERMANENT IMPAIRMENT OR DAMAGE REPORTED AND THE PATIENT'S MEDICAL CONDITION HAS SINCE IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132662 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND FCS9 UNKNOWN 00885825016012

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR