BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSA

    MDR report key: 547243 · Received September 30, 2004

    Report

    Report Number
    547243
    Event Type
    Other
    Date Received
    September 30, 2004
    Date of Event
    July 6, 2004
    Report Date
    September 30, 2004
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HERE FOR RIGHT HEPATIC LOBECTOMY/PUMP. CUSA TIP BENT DURING PROCEDURE OF RIGHT HEPATIC LOBECTOMY. CUSA STOPPED WORKING, NO INJURY TO PATIENT.PREOPERATIVE DIAGNOSIS: COLORECTAL LIVER METASTASES.POSTOPERATIVE DIAGNOSIS: COLORECTAL LIVER METASTASES.OPERATION PERFORMED: RIGHT HEPATIC LOBECTOMY, WEDGE RESECTION OF NODULE FROM LEFT LATERAL SEGMENT, INTRAOPERATIVE ULTRASOUND EXAMINATION OF LIVER, INSERTION OF HEPATIC ARTERY CHEMOTHERAPY PUMP, INFUSION STUDY THROUGH HEPATIC ARTERY PUMP.OP NOTE: "THE REMAINING HEPATIC PARENCHYMA WAS THEN DIVIDED USING THE CUSA DISSECTOR ALONG WITH THE ELECTROCAUTERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA SURGICAL DISSECTION SYSTEM GEI VALLEYLAB UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR