BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ CEM NOSECONE

    MDR report key: 5061863 · Received September 8, 2015

    Report

    Report Number
    3006697299-2015-00139
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    July 10, 2015
    Report Date
    August 17, 2015
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 09/23/2015. THE INVESTIGATION INCLUDED: METHOD: DHR REVIEW, REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. VISUAL INSPECTION. RESULTS: DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1150169 OF CUSA EXCEL 36KHZ CEM NOSECONE WAS REVIEWED. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. NO SIMILAR COMPLAINTS RELATED TO ¿FOREIGN MATERIAL¿ HAVE BEEN REPORTED FOR THIS LOT 1150169. (B)(4). ONE (1) UNOPENED PACKAGE OF AN UNUSED UNIT FROM CATALOG C6636, CUSA EXCEL 36KHZ CEM NOSECONE CORRESPONDING TO FG LOT # 1150169 WAS RECEIVED FOR EVALUATION IN ITS ORIGINAL PACKAGE. THE UNIT WAS RECEIVED COMPLETELY AND ACCEPTABLY SEALED. UPON INSPECTION, THE FOREIGN MATERIAL WAS OBSERVED ON THE NOSECONE CABLE. DURING THE INSPECTION, IT WAS OBSERVED THAT THE FOREIGN MATERIAL WAS A SMALL LOOSE PARTICULATE COLOR WHITE FOUND ON THE EXTERNAL SIDE OF THE TUBING. THE WHITE PARTICLE WAS COMPARED WITH TAPPI¿S DIRT CHART FINDING IT SIMILAR TO THE TAPPI¿S DIRT DOT WITH DIMENSION .40MM2 WHICH IS BIGGER THAN THE ACCEPTABLE DIMENSION ESTABLISHED IN PROC 3114 AND QCIC 2059 (.10MM2). CONCLUSION: THE FOREIGN MATERIAL ON THE PACKAGING WAS CONFIRMED WITH THE EVALUATION OF THE RETURNED UNIT. HOWEVER, THE ORIGIN OF THE PARTICLE COULD NOT BE DETERMINED. THE ORIGIN OF THIS FOREIGN MATERIAL COULD BE COMING FROM THE FORMING PROCESS OF THE TRAY AT THE SUPPLIER FACILITY OR FROM THE PACKAGING PROCESS, BUT NEITHER OF THEM COULD BE CONFIRMED. THEREFORE, THE ROOT CAUSE FOR THE FOREIGN MATERIAL INSIDE THE PACKAGING TRAY COULD NOT BE DETERMINED AT THIS TIME. RISK CONTROL PROCEDURES ARE IN PLACE TO REDUCE THE PROBABILITY OF OCCURRENCE OF THESE EVENTS. ALTHOUGH NO DEFINITE ROOT CAUSE WAS IDENTIFIED, A POTENTIAL ROOT CAUSE COULD BE THAT THE CLEANING PROCESS MAY HAVE NOT BEEN PERFORMED ADEQUATELY. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPO

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592422 CUSA EXCEL 36KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 0000001150169

    Patients

    Seq Age Sex Outcome Treatment
    1