BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ CURVED EXTENDED MICRO

    MDR report key: 8282756 · Received January 28, 2019

    Report

    Report Number
    3006697299-2019-00005
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Report Date
    January 10, 2019
    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 · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. NO ANOMALY WAS REPORTED TO INDICATE PRODUCT FAILURE DUE TO PACKAGING PROCESS OF THIS FG LOT. THE COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AT THIS TIME . THE PRODUCT IDENTIFIER NUMBER OF THIS REPORTED FG LOT IS (17)201031(10)2933055. THE UDI NUMBER FOR CATALOG (B)(4) IS 10381780026051.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C4611S CUSA EXCEL 36KHZ CURVED EXTENDED MICRO TIP WAS ON THE WRONG WAY WHEN USED WITH THE NOSECONE CEM. THE DATE OF THE INCIDENT WAS NOT PROVIDED. THE PRODUCT WAS NOT IN CONTACT WITH PATIENT. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE EVENT LEAD TO A SIGNIFICANT INCREASE OF SURGERY TIME OF 30 MINUTES. COMPLEMENTARY INFORMATION WAS RECEIVED ON 17JAN2019 INDICATING THAT THE PATIENT WAS ASLEEP WHEN THE ISSUE WAS DETECTED; THE SURGERY ALREADY STARTED BUT THE ISSUE WAS RECOGNIZED BEFORE USE. ANOTHER HANDPIECE WITH NEW TIP WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74738 CUSA EXCEL 36KHZ CURVED EXTENDED MICRO ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 2933055

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| NOSECONE CEM