BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 5976527 · Received September 26, 2016

    Report

    Report Number
    3006697299-2016-00185
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Report Date
    September 9, 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

    ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 27SEP2016: AN (B)(6) YEAR OLD MALE PATIENT WAS TO UNDERGO A LAPAROSCOPIC HEPATECTOMY. AS SOON AS THE OPERATION STARTED, THE PRODUCT ISSUE OCCURRED. THE COAG SETTING WAS EITHER TWIST OR SOFT COAG AT EFFECT 6-8 AND AMPLITUDE 60-80 SETTING. THE LOT NUMBER OF THE NOSECONE WAS EITHER 1160606 OR 1152675. THE HANDPIECE/NOSECONE WAS ON THE SURGICAL DRAPE WHEN IT DID NOT STOP ACTIVATING. THE PRODUCT WAS REPLACED WITH A NEW ONE FROM THEIR STOCK SUPPLY. THERE WAS ALSO NO INJURY TO THE USER.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/11/2016. THE INVESTIGATION INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE. -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOTS 1152675(DEVICE MANUFACTURE DATE 7/8/2015) AND 1160606 (DEVICE MANUFACTURE DATE 3/4/2016) OF CUSA 23KHZ CEM NOSECONE WERE REVIEWED. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESS OF THESE LOTS THAT COULD BE RELATED TO THE REPORTED CONDITION. AFTER REVIEWING THE INTEGRA LIFESCIENCES PR FACILITY COMPLAINT SYSTEM SINCE SEPTEMBER 2014 TO SEPTEMBER 2016, THIRTEEN (13) COMPLAINTS (INCLUDING THIS ONE) HAVE BEEN REPORTED RELATED TO THE REPORTED CONDITION IN CUSA NOSECONE FAMILY AT INTEGRA LIFESCIENCES PR FACILITY. (B)(4). CONCLUSION: CORROSION FORMING ON THE PCB AND LEAD WIRES INITIALLY, CREATES A SHORTING-CONDITION. THE CEM STAYS ACTIVATED UNTIL THE CONDITION IS BURNT OUT RESULTING IN AN OPEN CONDITION AS MEASURED DURING THE CONTINUITY AND HIGH VOLTAGE-INSULATION TEST. THE FINDINGS ARE CONSISTENT WITH CONTINUED ACTIVE USE OF THE CEM BEYOND THE RECOMMENDED INSTRUCTIONS FOR USE. EXCESSIVE USE CAUSES INTERNAL TEMPERATURES TO INCREASE AND MAY RESULT IS A CIRCUIT-SHORTING CONDITION CAUSING THE CEM TO STAY ACTIVE.

    Description of Event or Problem · 1

    DURING USE, THE BUTTON DID NOT STOP ACTIVATING WHEN THE USER RELEASED THE BUTTON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629347 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1