BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 4875607 · Received June 26, 2015

    Report

    Report Number
    3006697299-2015-00093
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 2, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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 INFO.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/04/2015 . THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: COMPLAINT CONFIRMED: THE NOSECONE FAILED THE CONDUCTIVITY TEST- THE OHM READING DID NOT DROP WHEN THE SWITCH WAS PRESSED. THE NOSECONE ALSO FAILED THE CIRCUIT INSULATION PROPERTY TEST, READING 0 MEGA OHMS. THE NOSECONE (P/N 72903913, "CUSA NOSECONE 23KHZ") PRODUCT IS MANUFACTURED BY (B)(4) SUPPLIER, KNOWN PREVIOUSLY AS OMNI PLASTICS, INC. (ALSO FPE LIFE SCIENCES), AND SHIPPED TO INTEGRA (B)(4) FOR PACKAGING AND STERILIZATION PROCESS. AS PART OF THE RELEASE PROCESS OF THE FG LOT #1144722, THE RELATED DOCUMENTATION WAS AUDITED BY PRODUCT RELEASE DEPARTMENT. THE FG LOT WAS RELEASED FOR DISTRIBUTION PURPOSE IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND QUALITY SYSTEM REQUIREMENTS OF INTEGRA. FOR THE COMPLAINTS OCCURRENCE RATE CALCULATION, APPLICABLE TO THIS INVESTIGATION, THE TIMEFRAME WAS DEFINED SINCE THE NEW IFU IMPLEMENTATION DATE OF JANUARY 17, 2014 - JUNE 5, 2015. WITHIN THIS PERIOD, (B)(4) COMPLAINTS HAVE BEEN REPORTED REGARDING THE REPORTED CONDITION IN CUSA NOSECONE; APPROXIMATELY (B)(4) UNITS OF CUSA NOSECONES PRODUCTS FAMILY HAVE BEEN RELEASED FOR DISTRIBUTION. THIS RESULTS IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). CONCLUSION: ROOT CAUSE FOR THE FAILURE MODE REPORTED IN THIS INCIDENT WAS THE ELECTRO-MIGRATION OF TIN (METAL USED AS A SOLDER) ACROSS THE PCB (PRINTED CIRCUIT BOARD) SWITCH CONTACTS.

    Description of Event or Problem · 1

    THE COAGULATION FUNCTION WAS ACTIVATED FROM THE START WITHOUT PRESSING THE COAG BUTTON AND COULD NOT BE TURNED OFF. IT WAS REPLACED WITH A NEW UNIT IMMEDIATELY WITHOUT ANY INJURY TO THE PT. ADDITIONAL INFO HAS BEEN REQUESTED AND THE FOLLOWING WAS RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2015. THE INCIDENT OCCURRED ON (B)(6) 2015 WHEN THE DOCTOR TRIED TO USE THE HANDPIECE FOR THE FIRST TIME DURING THE SURGERY (TYPE OF SURGERY UNK) ON A FEMALE PT. THE DOCTOR NOTICED THAT IT WAS ACTIVATED WHEN HE TRIED TO USE THE HANDPIECE. IT WAS UNK WHEN THE COAG WAS ACTIVATED AND WHAT THE SETTING WAS. THERE WAS JUST A FEW MINUTES DELAY IN SURGERY TO EXCHANGE THE NOSECONE. THERE WAS NO PT ADVERSE CONSEQUENCE AS A RESULT OF THE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414731 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1