BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 6396701 · Received March 10, 2017

    Report

    Report Number
    3006697299-2017-00045
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 9, 2017
    Report Date
    February 16, 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 4/25/2017. METHOD: DHR REVIEW, TREND ANALYSIS, FAILURE ANALYSIS. THE CUSA EXCEL 23KHZ CEM NOSECONE FINISHED GOODS NUMBER 1163069 WAS MANUFACTURED AFTER THE IMPLEMENTATION OF THE NEW PRINTED CIRCUIT BOARDS. INTEGRA BILLERICA PERFORMED THE FAILURE ANALYSIS TO THE COMPLAINT UNIT BUT WAS NOT ABLE TO DUPLICATE THE REPORTED CONDITION. METER READINGS OBTAINED PROPER MEASUREMENTS. A DESTRUCTIVE EVALUATION OF THE BUTTON AND RELATED ASSEMBLY FOUND NO RESIDUE, CORROSION OR DEFECT ON EACH LAYER INCLUDING THE SURFACE OF THE PRINTED CIRCUIT BOARD. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING AND STERILIZATION PROCESS OF THIS LOT THAT COULD DAMAGE THE PRODUCT INSIDE THE PACKAGE CAUSING THE RELATED TO THE CONDITION ¿BUTTON DID NOT STOP ACTIVATING COAGULATION WHEN THE USER DID NOT PUSH THE BUTTON¿. NO SIMILAR COMPLAINTS RELATED TO ¿BUTTON DID NOT STOP ACTIVATING COAGULATION WHEN THE USER DID NOT PUSH THE BUTTON¿ HAVE BEEN REPORTED FOR THE FG LOT 1163069. AFTER REVIEWING THE INTEGRA COMPLAINT SYSTEM SINCE FEBRUARY 2015 TO FEBRUARY 2017, ELEVEN (11) COMPLAINTS (INCLUDING THE ONE BEING INVESTIGATED) HAVE BEEN REPORTED RELATED TO THE REPORTED CONDITION IN CUSA NOSECONE FAMILY. COMPLAINTS ARE ASSOCIATED TO C6623. IMPLEMENTATION OF NEW POWER CIRCUIT BOARD FOR CATALOG C6636 OCCURRED BEFORE IMPLEMENTATION OF CATALOG C6623. CONCLUSION: THE PRODUCT WAS RETURNED BUT THE EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY THE COMPLAINT AS VALID. THEREFORE, AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED. NO ASSIGNABLE CAUSES AND/OR ANOMALIES AT MANUFACTURING PROCESS WHICH COULD CONTRIBUTE AND/OR BE RELATED WITH THE REPORTED INCIDENTS WERE IDENTIFIED.

    Description of Event or Problem · 1

    DURING USE, THE BUTTON DID NOT STOP ACTIVATING COAGULATION WHEN THE USER DID NOT PUSH THE BUTTON. THERE WAS NO PATIENT INJURY. THE NOSECONE WAS DETACHED FROM THE MONOPOLAR SOCKET ONCE. AFTER THAT, IT WAS CONNECTED AGAIN AND FUNCTIONED AS USUAL. THEY REPLACED WITH A NEW ONE FROM THEIR STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177821 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1163069

    Patients

    Seq Age Sex Outcome Treatment
    1