BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL

    MDR report key: 488779 · Received September 23, 2003

    Report

    Report Number
    MW1029632
    Event Type
    Malfunction
    Date Received
    September 23, 2003
    Date of Event
    June 21, 2003
    Report Date
    September 16, 2003
    Manufacturer
    VALLEYLAB DIV TYCO HEALTHCARE GR
    Product Code
    LBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/11/03: THE MEDWATCH SENT BY THE CUSTOMER IDENTIFIED THE CONSOLE, RATHER THAN THE CUSA TIP. THE CUSA TIP WAS NOT RETURNED TO VALLEYLAB FOR EVAL; HOWEVER, THE HANDPIECE HAD BEEN RETURNED TO VALLEYLAB'S SERVICE DEPT ON JULY 18TH, 2003. THE TEST RESULTS FOUND THE HANDPIECE TO OPERATE PROPERLY AND WITHIN ALL SPECS WHEN TESTED WITH A SPARE TEST TIP. THE HANDPIECE WAS DISASSEMBLED AND NO CONDITIONS WERE FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE TIP BREAKING. ALTHOUGH THE CAUSE OF THE CUSTOMER'S REPORT CANNOT BE DETERMINED, TIP BREAKAGE IS KNOWN TO OCCUR WHEN THE TIP IS PLACED IN CLOSE PROXIMITY TO ELECTROSURGICAL ENERGY DURING USE. THE TIP WILL PRODUCE A BLUISH COLOR, BUT AGAIN, THE TIP WAS NOT RETURNED FOR EXAM. PRODUCT LABELING CAUTIONS THE USER NOT TO USE THE TIP IN CLOSE PROXIMITY TO ELECTROSURGERY.

    Description of Event or Problem · 1

    TIP OF THE CUSA (ULTRASOUNIC SURGICAL ASPIRATOR) HANDPIECE BROKE WHILE IN USE. TIP RETRIEVED, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR LBK VALLEYLAB DIV TYCO HEALTHCARE GR CUSAEXCEL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *