BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL+

    MDR report key: 2544695 · Received April 17, 2012

    Report

    Report Number
    MW5025102
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 17, 2012
    Manufacturer
    INTEGRA LIFE SCIENCE
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED: I NOTICED THE CUSA WAS LEAKING FLUID SO I CHECKED IRRIGATION TUBING. TUBING WAS LOADED CORRECTLY IN THE "V" SLOTS BUT WHEN THE PUMP WAS OPENED THE TUBING WAS CAUGHT BETWEEN THE PUMP ROLLERS AND LATCH. THE TUBING HAD A TEAR WHERE IT WAS CAUGHT AND POTENTIALLY DELIVERED CONTAMINATED IRRIGATION TO THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA EXCEL+ ULTRACISION SURGICAL ASPIRATOR LFL INTEGRA LIFE SCIENCE EXCEL+

    Patients

    Seq Age Sex Outcome Treatment
    1