BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 6108917 · Received November 17, 2016

    Report

    Report Number
    3006697299-2016-00207
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 26, 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 12/30/16. METHOD: -DEVICE HISTORY REVIEW, -TREND ANALYSIS, -FAILURE ANALYSIS. THE DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1160606 OF CUSA 23KHZ CEM NOSECONE WAS REVIEWED. NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THIS LOT THAT COULD BE RELATED TO THE CONDITION ¿BUTTON DID NOT STOP ACTIVATING WHEN THE USER RELEASED THE BUTTON¿. A REVIEW OF THE COMPLAINT SYSTEM FROM OCTOBER 2014 TO OCTOBER 2016, SHOW ELEVEN (11) COMPLAINTS (INCLUDING THE ONE BEING INVESTIGATED) BEING REPORTED RELATED TO THE REPORTED CONDITION IN CUSA NOSECONE FAMILY. COMPLAINTS ARE ASSOCIATED TO C6623. IMPLEMENTATION OF NEW POWER CIRCUIT BOARD (PCB) FOR CATALOG C6636 OCCURRED BEFORE IMPLEMENTATION OF CATALOG C6623. ONE ADDITIONAL COMPLAINT WAS RECEIVED ON NOVEMBER 23, 2016 AND IS BEING INVESTIGATED. THE COMPLAINT OCCURRENCE RATE FOR THE REPORTED IS APPROXIMATELY 0.00018. A VISUAL INSPECTION OF THE RETURNED CEM NOSECONE FOUND NO VISIBLE, PHYSICAL DAMAGE. RESISTANCE MEASUREMENTS WERE PERFORMED UTILIZING A FLUKE MULTI-METER. FIVE READINGS TAKEN WITH THE BUTTON PRESSED MEASURED APPROXIMATELY 10.0 OHMS AND FIVE READINGS TAKEN WITH THE BUTTON UN-PRESSED MEASURED OPEN/HIGH IMPEDANCE AS EXPECTED. THE ACTIVATOR BUTTON WAS PERFORMING AS DESIGNED. HIGH VOLTAGE - INSULATION TESTING: FIVE READINGS TAKEN WITH THE BUTTON PRESSED MEASURED APPROXIMATELY 00.0 OHMS AND FIVE READINGS TAKEN WITH THE BUTTON UN-PRESSED MEASURED 1000 MOHMS/HIGH IMPEDANCE AS EXPECTED. THE ACTIVATOR BUTTON WAS PERFORMING AS DESIGNED. A DESTRUCTIVE EVALUATION WAS PERFORMED. IT WAS DETERMINED THE PRINTED CIRCUIT BOARD IN THIS CEM WAS THE OLD, PRE-CAPA REVISION. CONCLUSION: THE REPORTED COMPLAINT OF ¿CEM NOSECONE DID NOT STOP ACTIVATING WHEN HE BUTTON WAS RELEASED¿ WAS NOT DUPLICATED. THE FINDINGS ARE CONSISTENT WITH CONTINUED ACTIVE USE OF THE CEM BEYOND THE RECOMMENDED INSTRUCTIONS FOR USE. EXCESSIVE USE CAUSES INTERNAL TEMPERATURES TO INCREASE AND MAY RESULT IN A CIRCUIT-SHORTING CONDITION CAUSING THE CEM TO STAY ACTIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE C6623 CUSA EXCEL 23KHZ CEM NOSECONE WAS BEING USED FOR A LAPAROSCOPIC HEPATECTOMY WHEN THE BUTTON DID NOT STOP ACTIVATING DESPITE THE USER RELEASING IT. THE PROBLEM WAS FOUND IN THE BEGINNING OF THE PROCEDURE RIGHT AFTER THE BUTTON WAS PRESSED. THE TYPE OF TISSUE BEING REMOVED WAS LIVER TISSUE. THERE WAS NO PATIENT INJURY AND A NEW REPLACEMENT NOSECONE WAS USED FROM THE STOCK. THE PATIENT'S AGE, GENDER AND OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762332 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1