BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 5659579 · Received May 17, 2016

    Report

    Report Number
    3006697299-2016-00127
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    February 26, 2016
    Report Date
    April 21, 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 08/09/2016. THE INVESTIGATION INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: THREE SAMPLES OF LOT 1152105 WERE RETURNED FOR EVALUATION. - PARTICLE SEEMED TO BE INSIDE THE PACKAGE CLOSE TO THE SEALING AREA OF SEALED TRAY LOT 1152105/ CATALOG C6623. DURING EXAMINATION, THE PARTICLE WAS TOUCHED AND IT WAS NOTICED THAT IT WAS ON THE OUTSIDE OF THE PACKAGE. THE PARTICLE TRAVELED AND FINALLY IT WAS WIPED-OFF THE PACKAGE. SINCE THE PARTICLE WAS EXTERNAL TO THE PACKAGE, THE COMPLAINT IS CONSIDERED UNCONFIRMED - ALL THREE SAMPLES HAD LOOSED BANDS AND THUS CONFIRMED THE OPENED BANDS FAILURE. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOTS 1153753 AND 1152105 WERE REVIEWED. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THESE LOTS THAT COULD BE RELATED TO ANY OF THE TWO (2) THE REPORTED CONDITION. NONCONFORMANCE, SCAR, AND CAPA REPORTS REGARDING CUSA NOSECONE PRODUCTS WERE REVIEWED. NO ASSOCIATED NCR, SCAR AND/OR CAPA WERE FOUND TO BE RELATED TO THESE FAILURES. REVIEW OF PRODUCT'S COMPLAINT HISTORY FROM APRIL 2014 - APRIL 2016 (FOREIGN MATERIAL): NO SIMILAR COMPLAINTS RELATED TO ¿FOREIGN MATERIAL¿ HAVE BEEN REPORTED FOR THE ABOVE REPORTED FG LOTS. AFTER REVIEWING THE COMPLAINT SYSTEM FROM APRIL 2014 TO APRIL 2016, SEVEN (7) COMPLAINTS RELATED TO ¿FOREIGN MATERIAL¿ (INCLUDING THE TWO BEING INVESTIGATED) HAVE BEEN REPORTED IN THE CUSA NOSECONE FAMILY AT INTEGRA LIFESCIENCES PR FACILITY. APPROXIMATELY (B)(4) UNITS OF CUSA NOSECONE PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES FROM APRIL 2014 TO APRIL 2016, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY 0.0001. REVIEW OF PRODUCT'S COMPLAINT HISTORY FROM APRIL 2014 - APRIL 2016 (LOOSE BANDS): NO SIMILAR COMPLAINTS RELATED TO ¿THE WHITE BAND WAS COMING LOOSE INSIDE THE UNOPENED PACKAGE¿ HAVE BEEN REPORTED FOR THE ABOVE REPORTED FG LOTS. AFTER REVIEWING THE COMPLAINT SYSTEM FROM APRIL 2014 TO APRIL 2016, ELEVEN (11) COMPLAINTS RELATED TO ¿THE WHITE BAND WAS COMING LOOSE INSIDE THE UNOPENED PACKAGE¿ (INCLUDING THE ONES BEING INVESTIGATED) HAVE BEEN REPORTED IN THE CUSA NOSECONE FAMILY AT INTEGRA LIFESCIENCES (B)(4) FACILITY. APPROXIMATELY (B)(4) UNITS OF CUSA NOSECONE PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES FROM APRIL 2014 TO APRIL 2016, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY 0.0002. FOREIGN MATERIAL SINCE FOREIGN MATTER WAS NOT CONFIRMED, NO ROOT CAUSE WAS POSSIBLE AT THIS POINT. LOOSE BANDS. SELF-STICK PAPER BAND (P/N 232600027) IS PURCHASED FROM AN EXTERNAL SUPPLIER (HANSCOM, INC.). AT THE MOMENT IT IS UNKNOWN IF THE EVENTS COULD BE RELATED TO THE SELF-ADHESIVE PAPER. THE ROOT CAUSE FOR THIS EVENT IS UNDETERMINED; CAPA WAS ISSUED ON 05/19/16 IN ORDER TO ADDRESS THE INCREASE IN CONFIRMED INCIDENTS RELATED TO CUSA MANIFOLD TUBING FAMILY AND CUSA NOSECONE FAMILY REPORTING THE CONDITION ¿THE WHITE BAND COMING LOOSE¿.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME REPORTER, SAME PRODUCT, SIMILAR ISSUE, DIFFERENT LOT NUMBERS). LINKED TO MFG. REPORT NUMBER: 3006697299-2016-00126. AT THE INCOMING INSPECTION OF GOODS BY THE DISTRIBUTOR, THE WHITE BAND WAS FOUND TO BE COMING LOOSE INSIDE THE UNOPENED PACKAGES. FOREIGN MATERIAL WAS ALSO FOUND INSIDE THE PACKAGES. QUANTITY OF 3 PACKAGES WERE REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315785 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 0000001152105

    Patients

    Seq Age Sex Outcome Treatment
    1