BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 6091403 · Received November 9, 2016

    Report

    Report Number
    3006697299-2016-00203
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 18, 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 2/21/2017. -DHR REVIEW. -TREND REVIEW. -FAILURE ANALYSIS. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1163069 OF CUSA 23KHZ CEM NOSECONE WAS REVIEWED. NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. REVIEW OF THE COMPLAINT SYSTEM SINCE OCTOBER 2014 TO OCTOBER 2016 INDICATE THERE HAVE BEEN FIVE (5) COMPLAINTS (INCLUDING THE TWO BEING INVESTIGATED) REPORTED RELATED TO THE REPORTED CONDITION IN THE CUSA NOSECONE FAMILY. APPROXIMATELY (B)(4) UNITS OF CUSA NOSECONE PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES FROM OCTOBER 2014 TO OCTOBER 2016, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). CONCLUSION: THE EVALUATION CAN BE CLOSED; THE EVALUATION VERIFIED THE COMPLAINT AS VALID; THE CAUSE WAS VERIFIED AS CORROSION BUILD-UP ON THE CONTACT SURFACES RENDERING THE CEM NOSECONE BUTTON NON-FUNCTIONAL. FURTHER REVIEW IS NOT REQUIRED.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF THREE REPORTS (SAME PRODUCT ID, SAME USER FACILITY, SAME PRODUCT PROBLEM). LINKED TO MFR REPORTS: 3006697299-2016-00193 AND 3006697299-2016-00202. THE C6623 CUSA NOSECONE WAS NOT WORKING PROPERLY. THE INCIDENT HAPPENED DURING SURGERY AND THE SURGERY TIME WAS INCREASED FOR A FEW MINUTES WHILE ANOTHER NOSE-CONE WAS EXCHANGED. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE SURGEON WAS ABLE TO RESUME THE PROCEDURE ONCE IT WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742410 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 0000001163069

    Patients

    Seq Age Sex Outcome Treatment
    1