BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3212030 · Received July 8, 2013

    Report

    Report Number
    0001056128-2013-00100
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K100537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. A VISUAL EXAMINATION OF THE DEVICE REVEALED BIOLOGICAL MATERIAL FROM USE ON THE DISTAL TIP AND AN INDENTION IN THE TEFLON PAD. THE DEVICE DID NOT EXHIBIT ANY EVIDENCE OF OVERHEATING (THE BLADE WAS NOT CHARRED OR DISCOLORED). THE DEVICE WAS ACTUATED MULTIPLE TIMES AND CONFIRMED TO HAVE PROPER MECHANICAL FUNCTIONALITY. THE DEVICE WAS THEN CONNECTED TO A SCALPEL GENERATOR AND APPROPRIATE HAND PIECE. THE SCALPEL WAS TESTED (BY PRESSING THE GENERATOR TEST BUTTON) AND PASSED THE INITIAL TESTING. THE DEVICE WAS ABLE TO SUCCESSFULLY ACTIVATE WITH THE FOOT PEDALS AND BUTTONS (EACH BUTTON WAS TESTED TEN TIMES). EACH TIME THE MIN OR MAX BUTTON WAS PRESSED; THE DEVICE ACTIVATED AND AT NO TIME DID THE DEVICE FAIL TO ACTIVATE OR STOP WORKING. AFTER ACTIVATION, THE DEVICE DID NOT APPEAR TO HAVE EXCESSIVE RESIDUAL HEAT OF THE BLADE/DISTAL TIP. ULTRASONIC SCALPEL DEVICES GENERATE HEAT AS A RESULT OF MECHANICAL FRICTION DURING USE. REGARDING OVERHEATING AND BURNS, THE INSTRUCTIONS FOR USE (IFU) OF REPROCESSED ULTRASONIC FOCUS¿ CURVED SHEARS STATES: ¿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.¿ ¿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.¿ ¿DURING PROLONGED ACTIVATION, THE BLADE, THE CLAMP ARM, AND THE DISTAL END OF THE SHAFT MAY BECOME HOT. AT ALL TIMES AVOID UNINTENDED CONTACT WITH TISSUE, DRAPES, SURGICAL GOWNS, OR OTHER UNINTENDED SITES.¿ ¿AVOID INCIDENTAL AND PROLONGED ACTIVATION AGAINST SOLID SURFACES (SUCH AS BONE), WHICH MAY RESULT IN BLADE HEATING AND/OR BLADE FAILURE.¿ A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHAT USING AN ULTRASONIC SCALPEL DURING A PROCEDURE "IT WAS PERCEIVED THAT THE DEVICE CONTRIBUTED TO REDNESS ON THE PATIENT'S CHIN ABOVE THE INCISION SITE." THE PATIENT WAS GIVEN BACITRACIN AND NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309414 NA NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND FCS9 2462540

    Patients

    Seq Age Sex Outcome Treatment
    1