BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCEL 23KHZ STANDARDTIP BOX4

    MDR report key: 2163677 · Received June 14, 2011

    Report

    Report Number
    1222895-2011-00011
    Event Type
    Other
    Date Received
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    INTEGRA, BURLINGTON
    Product Code
    LFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE TOP OF THE CUSA EXCEL STANDARD TIP (4601) CRACKED AND BROKE DURING LIVER SURGERY. WHILE THE REPLACEMENT OF THE TIP WAS BEING DONE, THE PT LOST SOME BLOOD (BLOOD LOSS AMOUNT NOT PROVIDED). REPLACING THE TIP DID NOT SIGNIFICANTLY DELAY THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW TIP. A CEM NOSECONE WAS IN USE WITH THE TIP DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL 23KHZ STANDARDTIP BOX4 ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA, BURLINGTON 1100442

    Patients

    Seq Age Sex Outcome Treatment
    1