BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ CURVED EXTENDED MICRO

    MDR report key: 8438176 · Received March 20, 2019

    Report

    Report Number
    3006697299-2019-00038
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 26, 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 DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE FAILURE ANALYSIS TO IDENTIFY ROOT CAUSE TO THE END USER'S EXPERIENCE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD REVIEW SHOWED NO ANOMALY OBSERVED THAT COULD HAVE CAUSED THE REPORTED CONDITION. NO REJECTS WERE REPORTED DURING PRODUCT INSPECTIONS. ALSO, NO QUALITY EVENT WAS GENERATED FOR THE MENTIONED LOT; THEREFORE, THE LOT COMPLIED WITH ALL REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. THE REPORTED COMPLAINT WAS NOT CONFIRMED. DEVICE IDENTIFIER NUMBER: (B)(4). PRODUCT IDENTIFIER: (17)210930(10)3120783.

    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 DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT ON (B)(6) 2019, THE C4611S CUSA EXCEL 36KHZ CURVED EXTENDED MICRO WAS REJECTED DURING INCOMING INSPECTION DUE TO A FOREIGN MATERIAL NOTED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230524 CUSA EXCEL 36KHZ CURVED EXTENDED MICRO ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 3120783

    Patients

    Seq Age Sex Outcome Treatment
    1