BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP

    MDR report key: 8084576 · Received November 19, 2018

    Report

    Report Number
    3006697299-2018-00072
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 29, 2018
    Report Date
    October 30, 2018
    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. THE COMPLAINT IS UNCONFIRMED. ROOT CAUSE ANALYSIS CAN 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 C4614S IS (B)(4).

    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. LINKED TO MFG. REPORT NUMBER: 3006697299-2018-00071.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS. AN ACCOUNT MANAGER REPORTED ON BEHALF OF THE CUSTOMER THAT THE C4614S CUSA EXCEL 36KHZ CURVED EXTENDED STANDARD-TIP SEEMED TO BE THE WRONG WAY AROUND. THE DATE OF INCIDENT WAS (B)(6) 2018. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT; HENCE THE PATIENT WAS NOT INJURED. THE EVENT LED TO AN INCREASE IN SURGERY TIME FOR 30 MINUTES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 INDICATING THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO HARM TO THE PATIENT. THE CUSTOMER OPENED ANOTHER TIP AND TUBING UNTIL ONE FIT; THAT¿S WHEN THEY FINISHED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926368 CUSA EXCEL 36KHZ CURVED EXTENDED STANDARDTIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 2933055

    Patients

    Seq Age Sex Outcome Treatment
    1