BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL CONTAMINATION GUARD

    MDR report key: 3943561 · Received April 30, 2014

    Report

    Report Number
    3006697299-2014-00030
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE NURSE NEURO COORDINATOR REPORTED THAT THE CUSA EXCEL CONTAMINATION SEAL (C0005) CRACKED AND THEN BROKE ON (B)(6) 2014. THE PATIENT WAS AN ADULT WHO WAS ANESTHETIZED WHEN THE SURGERY FOR A BRAIN TUMOR WAS DELAYED FOR AN HOUR. THE PATIENT DID NOT INCUR AN INJURY BECAUSE OF THE DELAY OR THE EVENT. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY USING THE SAME UNIT DESPITE THE BROKEN SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258755 CUSA EXCEL CONTAMINATION GUARD ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED TL-256988

    Patients

    Seq Age Sex Outcome Treatment
    1