BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL 23KHZ STANDARDTIP

    MDR report key: 6077732 · Received November 3, 2016

    Report

    Report Number
    3006697299-2016-00197
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 3/01/2017. METHOD: -DHR REVIEW, -TREND ANALYSIS, - FAILURE ANALYSIS. THE DHR REVIEW CONDUCTED FOR FG LOT 1162081 SHOWED NO INDICATION THAT THE PRODUCTION PROCESS OF THIS LOT CONTRIBUTED TO THE COMPLAINT EVENT. NO ANOMALIES WERE REPORTED DURING THE MANUFACTURING AND PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM OCTOBER 2014 ¿ OCTOBER 2016, A TOTAL OF ELEVEN (11) COMPLAINTS (INCLUDED THE TWO INVESTIGATED UNDER THIS REPORT) RELATED TO ¿STANDARD TIP BROKE¿ FOR CUSA TIPS AND FLUES PRODUCTS FAMILY HAVE BEEN REPORTED. (B)(4). THREE CUSA EXCEL 23 KHZ TIPS WERE RECEIVED FOR EVALUATION. TIP 1) THIS TIP IS PRESENTED BY TWO PARTS, ONE IS THE ¿BROKEN END¿ AND OTHER PART IS THE ¿COMMON BODY¿. LENGTH OF THE ¿BROKEN END¿ IS EQUAL TO 6 MM. TIP WAS BROKEN IN THE PRE ASPIRATION HOLE ZONE. THE SURFACE CONDITION OF BOTH SECTIONS IS DISCOLORED A YELLOW-BLUE COLOR (BURNT) WHICH IS O CONSISTENT WITH THE TIP DURING A SURGERY. TIP 2) THIS TIP IS PRESENTED BY TWO PARTS, ONE IS THE ¿BROKEN END¿ AND OTHER PART IS THE ¿COMMON BODY¿. LENGTH OF THE ¿BROKEN END¿ IS EQUAL TO 5.5 MM. TIP WAS BROKEN IN THE PRE ASPIRATION HOLE ZONE. THE SURFACE CONDITION OF BOTH SECTIONS IS YELLOW-BLUE COLOR INDICATING THIS TIP HAS BEEN OVERHEATED DURING A PROLONGING HIS CONDITION IS ALSO CONSISTENT WITH THE TIP BEING LATERALLY OVERLOADED DURING A SURGERY. TIP 3) THIS TIP IS PRESENTED BY ONE ¿COMMON¿ PART AND IS NOT BROKEN. THIS TIP DOES NOT HAVE METAL TOOL MARKS OR DENTS. CAUTION & WARNING STATEMENTS FROM THE CUSA EXCEL/EXCEL+ USER MANUAL: - DURING SURGERY, UNDER MAXIMUM LOADING CONDITIONS, THE CUSA EXCEL/CUSA EXCEL+ CONSOLE IS SUITABLE FOR ULTRASONICS ACTIVATION TIMES OF 10 MINUTES ON, 5 MINUTES OFF. - CUSA EXCEL TIPS UTILIZE SILICONE FLUES. COMPRESSING THE FLUE AGAINST THE SIDE OF THE VIBRATING SURFACE ALONG THE LENGTH OF THE TIP CAN CAUSE EXCESSIVE HEATING AND POTENTIAL HAZARD TO ADJACENT TISSUE, SUCH AS BURNS. - AVOID EXCESSIVE LATERAL LOADING OF CUSA EXCEL TIPS. CONCLUSION: THE REPORTED COMPLAINT WAS COMPLAINT CONFIRMED. THE DAMAGE OBSERVED ON TWO OF THE TIPS ALONG WITH EACH BROKEN SECTION INDICATES HIGH TEMPERATURES LATERALLY OVERLOADED DURING A SURGERY AND IS CONSISTENT WITH OFF-LABEL USE OF REUSING THE TIP. THE THIRD TIP EXHIBITED NO VISIBLE, PHYSICAL DAMAGE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE C4601S CUSA EXCEL 23KHZ STANDARD TIP WAS BEING USED DURING A LIVER RESECTION ON A (B)(6) MALE PATIENT WHEN THE TIP BROKE. THE BROKEN PARTS WERE RETRIEVED AND THERE WAS NO PATIENT INJURY. ADDITIONAL CUSA TIPS WERE ON HAND. THERE WAS APPROXIMATELY A 30 MINUTE DELAY IN THE SURGERY WHILE COMPLETING THE CHANGEOVERS (2 CHANGEOVERS REQUIRING 15 MINUTES EACH). THE ILS SALES SPECIALIST REPORTED THAT NO CEM NOSECONE WAS USED. THE LIVER WAS DESCRIBED BY THE SURGEON AS "MILDLY FATTY" AND "NOT CIRRHOTIC". THE SURGEON REPORTED THAT THE 2 TIPS BOTH BROKE OFF IN MID-AIR AND NOT WHEN THEY WERE IN CONTACT WITH TISSUE. THIS HAS NOT BEEN SEEN BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728617 EXCEL 23KHZ STANDARDTIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1162081

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR