BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSA EXCEL 23KHZ STANDARDTIP

    MDR report key: 5351808 · Received January 7, 2016

    Report

    Report Number
    1222895-2015-00052
    Event Type
    Injury
    Date Received
    January 7, 2016
    Report Date
    December 14, 2015
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LINKED TO MDR #: 3006697299-2015-00179.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 28JAN2016. THE INVESTIGATION INCLUDED: METHODS: -REVIEW OF DEVICE HISTORY RECORDS, -REVIEW OF COMPLAINT HISTORY. THE DEVICE WAS NOT RETURNED FOR EVALUATION. RESULTS: THE DHR REVIEW HAS BEEN DEEMED SATISFACTORY. DATE OF MANUFACTURE: OCT 17 2012. THE DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED NON-CONFORMANCE ISSUES. THE ANALYSIS OF THE COMPLAINT INVESTIGATIONS AND ROOT CAUSE REPORTS HAS CONCLUDED THAT NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED HOWEVER THIS ISSUE WILL BE MONITORED. NO TREND HAS BEEN IDENTIFIED. CONCLUSION: THE DEVICE IN QUESTION WAS NOT RELEASED FOR EVALUATION THEREFORE THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE REOPENED SHOULD THE PRODUCT BE RECEIVED.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PRODUCT ID, SAME LOT NUMBER, SAME PRODUCT PROBLEM, DIFFERENT PATIENTS). THIS REPORT IS IN REGARDS TO THE SECOND PATIENT. DURING A HEPATIC SURGICAL PROCEDURE THE TIP BROKE. THE TIP WAS IN CONTACT WITH THE PATIENT HOWEVER THE PATIENT WAS NOT INJURED NOR WAS DEATH ALLEGED. THE EVENT DID LEAD TO AN INCREASE IN SURGERY TIME BY ONE TO TWO HOURS. THE SURGERY WAS COMPLETED USING CLASSICAL METHOD FOR THIS PROCEDURE. FURTHER INFORMATION WAS REQUESTED AND IS PENDING. LINK TO MDR: 3006697299-2015-00179.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8970 CUSA EXCEL 23KHZ STANDARDTIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA BURLINGTON, MA, INC. 1130786

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R