BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ TUBING SET

    MDR report key: 6142175 · Received December 2, 2016

    Report

    Report Number
    3006697299-2016-00216
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 14, 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

    INVESTIGATION COMPLETED (B)(6) 2017. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NO SIMILAR COMPLAINTS RELATED TO ¿HAIR INSIDE THE PACKAGE¿ HAVE BEEN REPORTED FOR THE FG LOT 1161804. A REVIEW OF COMPLAINTS FROM (B)(6) 2014 TO (B)(6) 2016, FOUR (4) COMPLAINTS RELATED TO ¿HAIR INSIDE THE PACKAGE¿ (INCLUDING THE COMPLAINT BEING INVESTIGATED) HAVE BEEN REPORTED IN THE CUSA MANIFOLD TUBING FAMILY. THE COMPLAINT OCCURRENCE RATE IS APPROXIMATELY 0.000016. THE VISUAL EVALUATION OF THE DEVICE IDENTIFIED THAT A HAIR WAS INSIDE THE PACKAGING. BASED ON THE DESCRIPTION OF THE REPORTED EVENT AND THE PRODUCT FAILURE ANALYSIS, THE REPORTED CONDITION ¿HAIR INSIDE THE PACKAGE¿ COULD NOT BE CONFIRMED SINCE THE ORIGINAL PACKAGE WAS OPENED. EVEN SO, THE IMPLEMENTATION OF AN OPEN FACE HOOD AS PART OF CAPA WAS IMPLEMENTED ON 09/15/16 AND THE MANUFACTURING DATE OF FG LOT 1161804 WAS BEFORE THE IMPLEMENTATION OF CAPA. 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. SINCE THE COMPLAINT UNIT WAS RECEIVED OPENED, AND THERE WAS NO ANOMALIES FOUND IN THE MANUFACTURING PROCESS THE POSSIBLE ROOT CAUSE MAY BE RELATED THAT A HAIR FELL INTO THE OPENED PACKAGING IN THE FIELD.

    Description of Event or Problem · 1

    THE C3600 CUSA EXCEL 23KHZ TUBING SET HAD A HAIR INSIDE THE PACKAGE. IT WAS DISCOVERED BY THE DISTRIBUTOR, ON 08 NOV 2016, BEFORE THE PRODUCT WAS IN USE, THUS THERE WAS NO PATIENT CONTACT, HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793719 CUSA EXCEL 23KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1