BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 4692960 · Received April 13, 2015

    Report

    Report Number
    3006697299-2015-00049
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 19, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 8/31/2015. THE INVESTIGATION INCLUDED: METHOD: DHR REVIEW. COMPLAINT TREND. VISUAL INSPECTION. RESULTS: MANUFACTURING DATES: LOT: 1140146 - 2/8/2014. LOT: 1141946 - 6/29/2014. THE DHRS OF THE FG LOTS # 1140146 AND 1141946 WERE REVIEWED AS PART OF THIS INVESTIGATION. THE FG LOTS WERE RELEASED FOR DISTRIBUTION PURPOSE IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND QUALITY SYSTEM REQUIREMENTS. A TWO YEAR LOOK BACK FOR THIS REPORTED FAILURE AND OR RELATED TO "DIATHERMY CONTINUED AFTER BUTTON RELEASED" FOR THIS PRODUCT ID SHOWS THAT (B)(4) COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. A CAPA WAS ISSUED TO FURTHER INVESTIGATE THIS REPORTED FAILURE. CONCLUSION: REPORTED FAILURE COULD NOT BE CONFIRMED OR REPRODUCED. HOWEVER THE BUTTON DID NOT ACTIVATE CEM WHEN PUSHED, WHICH DOES INDICATE A POSSIBLE ISSUE WITH THE SWITCH. LEAKAGE CURRENT WAS BELOW THE ACCEPTABLE LEVEL OF 2000MO (READ 1.5MO), WHICH MAY BE DUE TO A BREAKDOWN IN THE INSULATING PROPERTY OF THE SWITCH/ACTIVATION MECHANISM OF THE NOSECONE, AS OPPOSED TO ANOTHER PART OF THE CEM CIRCUIT. ADDITIONALLY, THE SWITCH CIRCUIT WAS READING GREATER THAN 2MO (READ 11.4MO), WHICH INDICATES AN OPEN CIRCUIT CONDITION IN THE CEM SWITCH. BUILDUP OF WHITE MATERIAL WAS NOTICED IN THE SWITCH, WHICH DOES NOT ALLOW SWITCH TO PRESS DOWN PROPERLY AND MAY BE INDICATIVE OF MATERIAL MIGRATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SECOND REPORT OF TWO INVOLVING THE SAME PRODUCT C6623 CUSA EXCEL CEM 23KHZ NOSECONE AND THE SAME PT. (MFR. REPORT NUMBER 3006697299-2015-00048 PR 125859). IT WAS REPORTED THAT THE DIATHERMY CONTINUED AFTER THE BUTTON WAS RELEASED DURING AN OPEN HEPATECTOMY-- SO THEREFORE NOTABLE STICKING. THERE WERE 2 NOSECONES WITH THE SAME ISSUE DURING THE 1 PROCEDURE- LOT# 1140146 X 1; LOT# 1141946 X 1. DELAY TO SURGERY APPROX 20 MINUTES WHILE THEY CHANGED OVER NOSECONES. NO ADVERSE PT OUTCOMES WERE REPORTED. THE SALES REP STATED THAT THIS SURGEON/HOSP ARE STILL AWARE OF THE ISSUE ABOUT CHANGING OVER THE NOSECONE AFTER 30 MINUTES AS PER IFU INSTRUCTIONS. SALES REP NOTED THAT IT WAS A DIFFICULT CASE THAT WAS PROLONGED AND DIATHERMY WAS ON FOR MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244434 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA NEUROSCIENCES PR 1140146

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR