BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23 KNZ CEM NOSECONE

    MDR report key: 4380105 · Received December 24, 2014

    Report

    Report Number
    3006697299-2014-00144
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    November 6, 2014
    Report Date
    December 3, 2014
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PRODUCT ID, SAME INCIDENT, SAME PT). THIS REPORT IS IN REGARDS TO THE SECOND/REPLACEMENT NOSECONE. DURING USE, THE ACTIVATION DID NOT STOP EVEN IF THE ACTIVATION SWITCH WAS RELEASED. THE USER REALIZED THE ABNORMAL CONDITION AND REPLACED WITH A NEW ONE. HOWEVER, THE SAME INCIDENT OCCURRED WITH THE REPLACED CEM NOSECONE WITHIN MINUTES. THERE WAS NO PT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850016 CUSA EXCEL 23 KNZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1