BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 6108916 · Received November 17, 2016

    Report

    Report Number
    3006697299-2016-00206
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 24, 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

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/23/2016: FAILURE ANALYSIS REQUIRES FUNCTIONAL TESTS BUT THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. THE REPORTING FACILITY (B)(4) INFORMED THAT THE FAILURE WAS REPRODUCED AND CONFIRMED AT THE DISTRIBUTION CENTER (B)(4). DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1151158 OF CUSA 23KHZ CEM NOSECONE WAS REVIEWED. THE MANUFACTURING DATE IS 03-25-15 AND FG LOT 1151158 EXPIRATION DATE IS 2018-04. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THIS LOT THAT COULD BE RELATED TO THE CONDITION ¿THE BUTTON DID NOT STOP ACTIVATING WHEN THE USER RELEASED THE BUTTON¿. NO PATIENT HARM WAS REPORTED AS PART OF THIS EVENT. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT 1151158 REGARDING THE REPORTED CONDITION (THE BUTTON DID NOT STOP ACTIVATING WHEN THE USER RELEASED THE BUTTON). AFTER REVIEWING THE INTEGRA LIFESCIENCES PR FACILITY COMPLAINT SYSTEM SINCE OCTOBER 2014 TO OCTOBER 2016, TEN (10) COMPLAINTS (INCLUDING THE ONE BEING INVESTIGATED) HAVE BEEN REPORTED RELATED TO THE REPORTED CONDITION IN CUSA NOSECONE FAMILY AT INTEGRA LIFESCIENCES PR FACILITY. CONCLUSION: THE CONDITION DESCRIBED AS ¿THE BUTTON DID NOT STOP ACTIVATING WHEN THE USER RELEASED THE BUTTON¿ COULD NOT BE CONFIRMED AT THIS TIME SINCE NO ASSIGNABLE CAUSES AND/OR ANOMALIES RELATED TO THIS CONDITION WERE IDENTIFIED BASED ON THE DHR REVIEW OF FG LOT 1151158. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED CONDITION AT THIS MOMENT.

    Description of Event or Problem · 1

    THE C6623 CUSA EXCEL 23KHZ CEM NOSECONE BUTTON DID NOT STOP ACTIVATING WHEN THE USER RELEASED THE BUTTON. THE FAILURE WAS REPRODUCED AND CONFIRMED BY THE DISTRIBUTOR WHEN IT WAS TESTED. THERE WAS NO PATIENT INJURY AND THE DEVICE WAS REPLACED WITH A NEW ONE FROM THE STOCK. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762233 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1