BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ TUBING SET

    MDR report key: 5245725 · Received November 24, 2015

    Report

    Report Number
    3006697299-2015-00166
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    August 18, 2015
    Report Date
    October 8, 2015
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LTD.
    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 (B)(4) 2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: TWO (2) UNOPENED PACKAGES OF UNUSED UNITS FROM CATALOG C3600, ¿23 KHZ TUBING SET¿ CORRESPONDING TO FG LOT # 1151252 WERE RECEIVED FOR EVALUATION IN ITS ORIGINAL PACKAGING ON (B)(4) 2015. UPON UNIT #1 INSPECTION, THE FOREIGN MATERIAL (SMALL LOOSE PARTICLE) WAS OBSERVED ON THE INNER TRAY (P/N 225200326). THE EVALUATION OF THE COMPLAINT UNIT #1 CONFIRMS THE REPORTED CONDITION SINCE A SMALL LOOSE PARTICULATE WAS OBSERVED INSIDE THE INNER TRAY. UPON UNIT #2 INSPECTION, THE FOREIGN MATERIAL WAS OBSERVED ON THE EXTERNAL SIDE OF THE TUBING. THE EVALUATION OF THE COMPLAINT UNIT #2 CONFIRMS THE REPORTED CONDITION SINCE A SMALL LOOSE PARTICULATE WAS OBSERVED ON THE EXTERNAL SIDE OF THE TUBING. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1151252 OF CUSA, 23 KHZ MANIFOLD TUBING SET, WAS REVIEWED. MANUFACTURE DATE OF FINISHED GOODS (FG) LOT 1151252 IS 04-2015 AND EXPIRATION DATE IS 04-2018. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE MANUFACTURING AND PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NONCONFORMANCE AND CAPA REPORTS WERE ALSO REVIEWED BUT NO SIMILAR CONDITIONS HAVE BEEN REPORTED SINCE 2013 ON THE CUSA MANIFOLD TUBING SET PRODUCTS. NO SIMILAR COMPLAINTS RELATED TO ¿FOREIGN MATERIAL¿ HAVE BEEN REPORTED FOR THIS LOT 1151252. AFTER REVIEWING THE COMPLAINT SYSTEM SINCE 2013, FIVE (5) COMPLAINTS (INCLUDING THIS ONE) RELATED TO FOREIGN MATERIAL HAS BEEN REPORTED IN CUSA MANIFOLD TUBING FAMILY. APPROXIMATELY 270,774 UNITS OF CUSA EXCEL TUBING SET PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES SINCE 2013 UNTIL 11/18/15, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY 0.002%. CONCLUSION: THE REPORTED CONDITION OF ¿FOREIGN MATERIAL¿ WAS CONFIRMED AS RESULT OF RETURNED UNITS. RISK CONTROL PROCEDURES AND SOPS ARE IN PLACED TO REDUCE THE PROBABILITY OF OCCURRENCE OF THESE EVENTS. TWO CLEANING TECHNIQUES¿ALCOHOL WIPES AND AIR BLOW-OFFS ARE USED IN OUR MANUFACTURING OPERATIONS, BOTH OF WHICH SEEK TO ELIMINATE UNWANTED PARTICLES ON DEVICE SURFACES. DURING THE MANUFACTURING PROCESS, THE MANIFOLD TUBING IS CLEANED WITH ALCOHOL WIPES. THIS METHOD REMOVES THE STATIC CHARGE ON THE SURFACE TEMPORARILY. ONCE THE ALCOHOL WIPE-DOWN HAS BEEN PERFORMED, AIR BLOW-OFFS IS FOLLOWED. TO ELIMINATE ALL PARTICLES, THE MANIFOLD TUBING ASSEMBLY IS SPRAYED WITH IONIZING AIR. IONIZED AIR BLOW-OFFS ARE EFFECTIVE AT REMOVING PARTICLES FROM THE DEVICE SURFACE, PREVENTING RECHARGING AND SUBSEQUENT PARTICLE ATTRACTION. THE COMPLETION OF THESE STEPS WAS REVISED DURING THE DHR REVIEW. FOR THIS PARTICULAR LOT, NO ANOMALIES WERE FOUND. UNITS ARE 100% INSPECTED FOR CONTAMINATION AND FOREIGN MATERIAL ON THE DEVICE. NO ANOMALIES RELATED TO THE REPORTED CONDITION WERE OBSERVED DURING THE MANUFACTURING PROCESS OF THE LOT 1151252 ACCORDING TO THE DHR REVIEW. ALTHOUGH NO DEFINITE ROOT CAUSE WAS IDENTIFIED, A POTENTIAL ROOT CAUSE COULD BE THAT THE CLEANING PROCESS MAY HAVE NOT BEEN PERFORMED ADEQUATELY.

    Description of Event or Problem · 1

    AT THE INCOMING INSPECTION OF GOODS BY THE DISTRIBUTOR, FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777634 CUSA EXCEL 23KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LTD. 0000001151252

    Patients

    Seq Age Sex Outcome Treatment
    1