BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ CEM NOSECONE

    MDR report key: 5464700 · Received February 26, 2016

    Report

    Report Number
    3006697299-2016-00102
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    January 28, 2016
    Report Date
    February 3, 2016
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11 MAR 2016. THE INVESTIGATION INCLUDED: UNABLE TO EVALUATE DEVICE. METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. FAILURE ANALYSIS HAS NOT BEEN PERFORMED SINCE THE COMPLAINT UNIT HAS NOT BEEN RECEIVED BY INTEGRA, BURLINGTON FOR EVALUATION. THE COMPLAINT MATERIAL WAS DELIVERED VIA (B)(4) FOR DECONTAMINATION ON (B)(6) 2016. THE COMPLAINT MATERIAL WAS AUTOCLAVED IN ATTEMPT TO DECONTAMINATE RESULTING IN THE MELTING OF THE PRODUCT. THE DHR REVIEW HAS BEEN DEEMED SATISFACTORY. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1152107 OF CUSA 23KHZ 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. CONCLUSION: THE REPORTED CONDITION COULD NOT BE CONFIRMED SINCE THE UNIT WAS MELTED DURING THE DECONTAMINATION PROCESS. IT IS NOT POSSIBLE DETERMINE A DEFINITE ROOT CAUSE .

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED THAT THE (B)(4) CEM NOSECONE SELF-ACTIVATED THE DIATHERMY DURING A PROCEDURE ON (B)(6) 2016. IT IS UNKNOWN IF THE PRODUCT WAS IN CONTACT WITH THE PATIENT HOWEVER IT WAS REPORTED THAT A PATIENT WAS NOT HARMED, INJURED NOR WAS DEATH ALLEGED. THE DEVICE WAS IN USE BY A DOCTOR AT THE TIME. IT IS UNKNOWN IF THE EVENT LEAD TO AN INCREASE IN SURGERY TIME. THE FAULTY NOSECONE WAS REMOVED AND REPLACED. THE DEVICE WILL BE RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED AND PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120085 CUSA EXCEL 23KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1152107

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR