BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 6558395 · Received May 10, 2017

    Report

    Report Number
    3006697299-2017-00074
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Report Date
    April 20, 2017
    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 (B)(6) 2017. DEVICE HISTORY RECORD (DHR) OF THE FINISH GOODS LOT # 1163070 WAS REVIEWED TO DETECT ANY ANOMALIES THAT COULD HAVE OCCURRED DURING THE PACKAGING PROCESS OF THE PRODUCT THAT COULD HAVE CONTRIBUTED AND/OR BE RELATED WITH THE REPORTED CONDITION BEING INVESTIGATED. MANUFACTURING (PACK) DATE: (B)(6) 2016. REVIEW OF COMPLAINT SYSTEM SINCE (B)(6) 2015 TO APRIL 2017 SHOW TEN (10) COMPLAINTS (INCLUDING THE ONE BEING INVESTIGATED) HAVE BEEN REPORTED RELATED TO THE REPORTED CONDITION IN CUSA NOSECONE FAMILY. APPROXIMATELY 56,904 UNITS OF CUSA NOSECONE PRODUCTS HAVE BEEN RELEASED FROM APRIL 2015 TO (B)(6) 2017, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY 0.00018. THE EVALUATION OF THE RETURNED C6623 CUSA EXCEL 23KHZ CEM NOSECONES DETERMINED THAT THEY HAD FAILED. THE REPORTED COMPLAINT IS CONSIDERED TO BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAD TWO 23KHZ CEM NOSECONE BUTTON STICK AND STAY ACTIVATED. THE DEVICES WERE IN CONTACT WITH THE PATIENT BUT THERE WAS NO HARM TO THE PATIENT. A 5 MINUTE DELAY IN SURGERY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340126 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1