BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ TUBING SET

    MDR report key: 5250976 · Received November 25, 2015

    Report

    Report Number
    3006697299-2015-00169
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    October 13, 2015
    Report Date
    November 5, 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 12/23/2015. THE INVESTIGATION INCLUDED: RESULTS: ONE (1) UNIT FROM CATALOG C3601, CUSA EXCEL 36KHZ TUBING SET CORRESPONDING TO FG LOT # 1151813 WAS RECEIVED FOR EVALUATION IN ITS ORIGINAL PACKAGING. RETURNED UNIT WAS RECEIVED COMPLETELY AND ACCEPTABLY SEALED. UPON INSPECTION, A SMALL LOOSE PARTICULATE WAS OBSERVED INSIDE THE OUTER TRAY (PART NUMBER 225200398). IT WAS OBSERVED THAT THE PARTICULATE WAS CLEAR AND WITH A SMOOTH-TEXTURED. THE EVALUATION OF THE COMPLAINT UNIT CONFIRMS THE REPORTED CONDITION SINCE A SMALL AND CLEAR LOOSE PARTICULATE WAS OBSERVED INSIDE THE OUTER TRAY. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1151813 OF CUSA EXCEL 36 KHZ TUBING SET, WAS REVIEWED. MANUFACTURE DATE OF FG LOT 1151813 IS 05/15/2015 AND EXPIRATION DATE 05/2018. 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. THE PACKAGING OPERATION WAS STARTED ON 05/12/2015 FOLLOWING THE PROCEDURE. PRIOR TO THE FIRST PACKAGING OPERATION ALL WORK SURFACES AND EQUIPMENT WERE WIPED WITH LINT FREE WIPE AND 100 % ISOPROPYL ALCOHOL IN ORDER TO EXCLUDE PHYSICAL CONTAMINANTS FROM ALL PHASES OF THE PACKAGING PROCESS. EACH PACKAGING TRAY WAS CLEANED UP WITH ALCOHOL 70% AND LINT FREE WIPE. AS PART OF THE PACKAGING OPERATION 100, EACH COILED MANIFOLD TUBING UNIT WAS SPRAYED USING AN IONIZING AIR GUN. EACH UNIT WAS THEN PLACED ONTO AN INNER TRAY AND THE INNER TRAY WAS PLACED INSIDE THE OUTER TRAY. DURING THE LAST STEP OF PACKAGING OPERATION 100, THE OUTER TRAY AND THE UNIT WERE SPRAYED USING THE IONIZING AIR GUN. ALL SEALED UNITS WERE 100% VISUALLY INSPECTED BY QA PERSONNEL ACCORDING TO SOP. ALSO, SAMPLES OF THE FG LOT WERE INSPECTED AND TESTED BY THE QA PERSONNEL FOR SEAL INTEGRITY (VISUAL INSPECTION, BURST TEST, AND PEEL APART VISUAL INSPECTION AFTER BURST TEST) AND NO ANOMALIES OR DISCREPANCIES WERE REPORTED DURING THESE ACTIVITIES. (B)(4). CONCLUSION: THE REPORTED CONDITION DESCRIBED AS ¿FOREIGN MATTER¿ WAS CONFIRMED WITH THE RETURNED UNIT. 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 1151813 ACCORDING TO THE DHR REVIEW. ALTHOUGH NO DEFINITE ROOT CAUSE WAS IDENTIFIED, CLEANING PROCESS (POTENTIAL CAUSAL FACTOR) MAY HAVE NOT BEEN PERFORMED ADEQUATELY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781271 CUSA EXCEL 36KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LTD. 0000001151813

    Patients

    Seq Age Sex Outcome Treatment
    1