BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ TUBING SET

    MDR report key: 5279061 · Received December 9, 2015

    Report

    Report Number
    3006697299-2015-00173
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    September 7, 2015
    Report Date
    October 8, 2015
    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 (B)(6) 2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: ONE (1) UNOPENED UNIT FROM CATALOG C3601, CUSA MANIFOLD TUBING SET CORRESPONDING TO FG LOT # 1151263 WAS RECEIVED FOR EVALUATION IN ITS ORIGINAL PACKAGING. RETURNED UNIT WAS RECEIVED COMPLETELY AND ACCEPTABLY SEALED. UPON INSPECTION, A HAIR WAS OBSERVED IN THE OUTER TRAY SEALING AREA. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1151263 OF CUSA EXCEL 36 KHZ TUBING SET, WAS REVIEWED. MANUFACTURE DATE OF FG LOT 1151263 IS 04/09/2015 AND EXPIRATION DATE 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. 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. AFTER REVIEWING THE COMPLAINT SYSTEM SINCE 2013, FOUR (4) COMPLAINTS RELATED TO ¿HAIR INSIDE OF PACKAGE¿ HAS BEEN REPORTED IN CUSA MANIFOLD TUBING FAMILY AT INTEGRA PR FACILITY. APPROXIMATELY(B)(4) UNITS OF CATALOGS C3600 AND C3601 HAVE BEEN SHIPPED FOR SALES PURPOSES SINCE 2013 UNTIL 12/04/15, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4)%. CONCLUSION: RISK CONTROL PROCEDURES AND SOPS ARE IN PLACE TO REDUCE THE PROBABILITY OF OCCURRENCE OF THESE EVENTS. TWO CLEANING TECHNIQUES¿ (B)(4) AND (B)(4) 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 (B)(4). THIS METHOD REMOVES THE STATIC CHARGE ON THE SURFACE TEMPORARILY. ONCE THE (B)(4) HAS BEEN PERFORMED, (B)(4) IS FOLLOWED. TO ELIMINATE ALL PARTICLES, THE MANIFOLD TUBING ASSEMBLY IS SPRAYED WITH (B)(4). (B)(4) 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 1151263 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

    DURING INCOMING INSPECTION OF GOODS BY THE DISTRIBUTOR, A HAIR INSIDE THE PACKAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809504 CUSA EXCEL 36KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 0000001151263

    Patients

    Seq Age Sex Outcome Treatment
    1