BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2801855 · Received October 23, 2012

    Report

    Report Number
    1056128-2012-00119
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH 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. THE TEFLON PAD WAS MELTED DOWN THE CENTER AND LOOSE PARTICLES WERE PRESENT ON THE PAD. A GREEN PLASTIC MATERIAL WAS OBSERVED MELTED ON THE DEVICE BLADE. THE SHAFT ROTATION AND THE JAW ACTUATION OF THE DEVICE WERE FOUND TO BE ACCEPTABLE. PRIOR TO GENERATOR ACTIVATION TESTING, THE MAJORITY OF THE GREEN DEBRIS WAS COLLECTED FOR MATERIAL IDENTIFICATION TEST; HOWEVER, SOME DEBRIS REMAINED ON THE BLADE. THE SCALPEL'S ACTIVATION WAS TESTED ON A GENERATOR AND THE DEVICE PASSED INITIAL, BUTTON (EACH BUTTON WAS TESTED 10 TIMES), AND PEDAL TESTING. TO DETERMINE IF THE DEVICE WAS OVERHEATING, THE DEVICE WAS ACTIVATED AT THE MAX SETTING OF 5 FOR A PERIOD OF 30 MINUTES. THE DEVICE WAS ACTIVATED IN 10 SECOND INTERVALS, AND THE TEMPERATURE WAS MEASURED IN 5 MINUTE INTERVALS. THE MAXIMUM READING RECORDED WAS 45.4 C. THE HIGHEST TEMPERATURE READING WAS IN THE AREA WHERE THERE WAS ADHERENT GREEN DEBRIS WHICH WAS LIKELY DUE TO MECHANICAL FRICTION BETWEEN THE BLADE AND DEBRIS. THE GREEN DEBRIS WAS FORWARDED TO THE R&D LAB FOR FT-IR TESTING AND WAS IDENTIFIED AS POLYETHYLENE. A REVIEW OF THE DEVICE MASTER RECORD DID NOT IDENTIFY ANY POTENTIAL SOURCES OF GREEN POLYETHYLENE. HOWEVER, POLYETHYLENE IS USED THROUGHOUT THE MEDICAL INDUSTRY IN PROTECTIVE COVERINGS SUCH AS DRAPES. DURING PROLONGED ACTIVATION THE DISTAL TIP OF THE DEVICE CAN BECOME HOT. IF THE HEATED TIP MAKES CONTACT WITH A DRAPE, THE MATERIAL CAN MELT ONTO THE DISTAL TIP. MOST LIKELY THE DEBRIS WAS INADVERTENTLY TRANSFERRED TO THE DISTAL TIP OF THE DEVICE DURING CLINICAL USE POSSIBLE WHEN THE DEVICE WAS LAID ON THE MAGNETIC TAB AS REPORTED. SSS INSTRUCTIONS FOR USE STATE: "TAKE CARE TO AVOID APPLICATION OF PRESSURE BETWEEN THE BLADE AND TISSUE PAD WITHOUT TISSUE IN BETWEEN THEM AS THIS CAN RESULT IN DAMAGE TO THE INSTRUMENT. THIS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER O THE FOOT PEDALS IS DEPRESSED." "THE USE OF THESE INSTRUMENTS REQUIRES A THOROUGH UNDERSTANDING OF THE TECHNIQUES AND PRINCIPLES O 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." "WHILE NOT IN USE, THE INSTRUMENT'S BLADE SHOULD BE KEPT OUT OF CONTACT WITH THE PATIENT, DRAPES, OR FLAMMABLE MATERIALS IN THE CASE THAT ACCIDENTAL ACTIVATION OCCURS." "DURING PROLONGED ACTIVATION, THE BLADE, THE CLAMP ARM, AND THE DISTAL 7 CM OF THE SHAFT MAY BECOME HOT. AVOID UNINTENDED CONTACT WITH TISSUE, DRAPES, SURGICAL GOWNS, OR OTHER UNINTENDED SITES AT ALL TIMES." "AVOID INCIDENTAL AND PROLONGED ACTIVATION AGAINST SOLID SURFACES, SUCH AS BONE, AS THIS MAY RESULT IN BLADE HEATING AND SUBSEQUENT 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 DURING A PROCEDURE THE TEFLON PAD OF THE ULTRASONIC SCALPEL MELTED AND FELL INTO THE SURGICAL SITE. THE PHYSICIAN WAS ABLE TO IRRIGATE AND REMOVE ALL THE PIECES. THE DEVICE WAS "THEN LAID ON THE MAGNETIC TAB AND THE DEVICE MELTED ON TO IT." NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS ACE23E 2095637

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR