BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STANDARD TIP

    MDR report key: 2573039 · Received May 9, 2012

    Report

    Report Number
    1222895-2012-00010
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE EXCEL CUSA TIP COMPLETELY SHEARED AND SNAPPED OFF 45 MINUTES INTO LIVER SURGERY. THE PT WAS ANESTHETIZED DURING THIS EVENT; HOWEVER, THE PT WAS NOT INJURED. THE SURGERY WAS DELAYED FOR TEN MINUTES WHILE ANOTHER TIP WAS OBTAINED AND PUT ON THE HAND PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA EXCEL 23KHZ STANDARD TIP ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1