BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3083665 · Received April 29, 2013

    Report

    Report Number
    0001056128-2013-00051
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    January 25, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    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. EXAMINATION OF THE RETURNED DEVICE REVEALED EVIDENCE OF CLINICAL USE AND THERE WAS AN INDENTION IN THE TEFLON PAD. THE SHAFT ROTATION AND THE JAW ACTUATION OF THE DEVICE WERE FOUND TO BE ACCEPTABLE. THE DEVICE WAS CONNECTED TO A SCALPEL GENERATOR. THE SCALPEL WAS TESTED AND PASSED THE INITIAL TESTING. THE DEVICE WAS SUCCESSFULLY ACTIVATED WITH THE FOOT PEDALS AND BUTTONS. EACH BUTTON WAS TESTED TEN TIMES. EACH TIME THE MIN OR MAX BUTTON OR PEDAL WAS PRESSED, THE DEVICE ACTIVATED AND AT NO TIME DURING TESTING DID THE DEVICE OR THE BUTTONS STOP WORKING. THE ABILITY OF THE DEVICE TO CUT AND COAGULATE WAS TESTED USING THE SAME GENERATOR WITH MIN AND MAX SETTINGS OF 3 AND 5 RESPECTIVELY AND LIVER AS THE TEST MEDIUM. THE DEVICE PASSED ALL CUT AND COAGULATION TESTING. CUTTING/COAGULATION EFFECTIVENESS IS RELATED TO VARIOUS FACTORS SUCH AS, BUT NOT LIMITED TO, POWER LEVEL (GENERATOR SETTINGS) AND SURGICAL TECHNIQUE. THE ULTRACISION HARMONIC SCALPEL GENERATOR 300 SYSTEM USER MANUAL STATES: "WITH ALL INSTRUMENTS EXCEPT THE BALL COAGULATOR, USE A HIGHER GENERATOR POWER LEVEL FOR GREATER TISSUE CUTTING SPEED AND A LOWER GENERATOR POWER LEVEL FOR GREATER COAGULATION." SSS INSTRUCTIONS FOR USE STATE: "USE A HIGHER POWER LEVEL FOR GREATER TISSUE CUTTING SPEED AND A LOWER POWER LEVEL FOR GREATER COAGULATION. THE AMOUNT OF ENERGY DELIVERED TO THE TISSUE PAD AND RESULTANT TISSUE EFFECTS ARE A FUNCTION OF NUMEROUS FACTORS INCLUDING POWER LEVEL, BLADE CHARACTERISTICS, GRIP FORCE, TISSUE TENSION, TISSUE TYPE, PATHOLOGY, AND SURGICAL TECHNIQUE." "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 OF THE FOOT PEDALS IS DEPRESSED." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 1056128-2012-00092 WHERE THE PHYSICIAN HAD TO SWITCH TO AN OPEN PROCEDURE DUE TO A VESSEL NOT BEING SEALED, EVEN THOUGH THERE WAS NO PATIENT INJURY IN THIS EVENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MDR HAD THE INCORRECT PRODUCT CODE AND MODEL NUMBER LISTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE ULTRASONIC SCALPEL "DID NOT SATISFACTORILY SEAL THE UTERINE VESSELS." NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE ULTRASONIC SCALPEL "DID NOT SATISFACTORILY SEAL THE UTERINE VESSELS." NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185316 NA NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ACE36E 1938382

    Patients

    Seq Age Sex Outcome Treatment
    1