BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 5781817 · Received July 11, 2016

    Report

    Report Number
    3006697299-2016-00154
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 15, 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

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 05 AUG 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE; REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: A VISUAL INSPECTION OF THE RETURNED NOSECONE FOUND NO VISIBLE, PHYSICAL DAMAGE. OHM METER MEASUREMENT WAS PERFORMED ACROSS THE CONTACT PINS FOR THE ACTIVATION BUTTON. DEPRESSING THE BUTTON MEASURED ~0.17 OHMS / CONTINUITY, RELEASING THE BUTTON MEASURED "OPEN" OHMS. THE ACTIVATION BUTTON WAS FUNCTIONING PROPERLY. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1150474 OF CUSA 23KHZ CEM NOSECONE WAS REVIEWED. THE NOSECONE COMPONENT PART NUMBER 72903913 IS RECEIVED AT INCOMING WITH A CERTIFICATE OF COMPLIANCE FROM THE SUPPLIER. INCOMING INSPECTION AT INTEGRA (B)(4) FOR P/N 72903913 CONSISTS ON A VISUAL INSPECTION FOR CONTAMINATION AND OTHER VISUAL DEFECTS. FUNCTIONAL TESTS ARE NOT REQUIRED DURING THE INCOMING INSPECTION AT INTEGRA, (B)(4) SINCE THE COMPONENT IS RECEIVED WITH ITS CERTIFICATE OF COMPLIANCE. QUALITY ASSURANCE PERSONNEL INSPECT UNITS FOR VISUAL DEFECTS AND ANY CONTAMINATION ON THE TRAY AND THE PRODUCT. UPON THE PACKAGING OPERATION COMPLETION, THE FG LOTS ARE SENT TO AN OUTSIDE COMPANY FOR THE STERILIZATION PROCESS AND RETURNED TO INTEGRA, IN (B)(4) FOR THE RELEASE PROCESS. SINCE THE FINISHED GOODS (FG) LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. (B)(4). CONCLUSION: THE RETURNED C6623 CUSA EXCEL 23KHZ CEM NOSECONE DISPLAYED NO VISIBLE, PHYSICAL DAMAGE. FUNCTIONAL TESTING DETERMINED THE BUTTON WAS OPERATING PROPERLY. THE REPORTED COMPLAINT OF ¿WOULD NOT STOP COAGULATING EVEN WHEN THE BUTTON WAS NOT PUSHED¿ WAS UNCONFIRMED. THE FINDINGS ARE CONSISTENT WITH PRODUCT USE BEYOND THE INSTRUCTIONS FOR USE REGARDING DUTY CYCLE AND TOTAL LENGTH OF ACTIVATION BUT, THE ACTUAL ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE C6623 CUSA EXCEL 23KHZ CEM NOSECONE WOULD NOT STOP COAGULATING. ON (B)(6) 2016, THE PATIENT WAS PREPPED FOR LIVER CANCER SURGERY WHEN IN THE MIDDLE OF THE PROCEDURE THE DEVICE PROBLEM OCCURRED. THE DEVICE HAD BEEN IN USE FOR 10 MINUTES. THERE WAS NO OTHER NOSECONE AVAILABLE FOR USE AND THE PRODUCT PROBLEM CAUSED A 10 MINUTE DELAY IN SURGERY TIME. THERE WAS NO PATIENT INJURY / DEATH ALLEGED AND NO REVISIONS OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438002 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1