BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ TUBING SET

    MDR report key: 4898286 · Received July 6, 2015

    Report

    Report Number
    3006697299-2015-00101
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 16, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION. THE INVESTIGATION INCLUDED: (B)(4). DHR REVIEW: REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. VISUAL. RESULTS: THE DHR REVIEW OF THE FG LOT # 1150420 WAS RELEASED FOR DISTRIBUTION PURPOSE ON 03/04/2015 IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS. NO ANOMALY OR DISCREPANCY WAS REPORTED DURING THE PACKAGING AND STERILIZATION PROCESSES OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NO OTHER COMPLAINTS HAVE BEEN ISSUED REGARDING FG LOT # 1150420. AFTER REVIEWING THE COMPLAINT SYSTEM SINCE 2013 TO THE PRESENT, (B)(4) COMPLAINTS RELATED TO ¿DAMAGED PACKAGE¿ HAVE BEEN ISSUED IN CUSA MANIFOLD TUBING SET PRODUCTS (CATALOGS: C3600 AND C3601). APPROXIMATELY (B)(4) UNITS OF CATALOGS C3600 AND C3601 HAVE BEEN RELEASED FOR SALES SINCE 01/01/2013 - 07/10/2015, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4)%. UPON CLOSER EXAMINATION OF THE RETURNED PRODUCT, A SMALL PERFORATION ALONG WITH A CUT WAS OBSERVED ON THE EXTERIOR SURFACE OF THE OUTER TRAY. THE TYVEK LID WAS REMOVED TO EVALUATE THE SEAL AREA. THE SEAL AREA WAS FOUND ACCEPTABLE: COMPLETE TRANSFER OF THE ADHESIVE FROM THE TYVEK TO THE PACKAGE AND NO VOIDS OR SPACES ACROSS THE SEAL WIDTH. CONCLUSION: BASED ON PRODUCT FAILURE ANALYSIS, THE REPORTED CONDITION (DAMAGED PACKAGING) WAS CONFIRMED. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS WERE DETERMINED BASED ON THE REVIEW OF THE DHR, CAPA'S, NCR'S AND SCAR'S HISTORY. IN ADDITION, PROCESS CONTROLS ARE IN PLACE TO DETECT THE REPORTED CONDITION (DAMAGED PACKAGING). ALTHOUGH A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED, BASED ON THE TYPE OF DAMAGE NOTICED ON THE OUTER TRAY (SMALL PERFORATION AND CUT), A POTENTIAL ROOT CAUSE FOR THE REPORTED CONDITION COULD HAVE BEEN CAUSED BY A SHARP OBJECT DURING PRODUCT HANDLING.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    AT THE INCOMING INSPECTION OF GOODS BY THE DISTRIBUTOR, THE PRODUCT WAS REJECTED DUE TO THE BROKEN PLASTIC PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434854 CUSA EXCEL 23KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1