BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAE UNK AQM GENERATOR

    MDR report key: 6020480 · Received October 12, 2016

    Report

    Report Number
    1226420-2016-00152
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    April 1, 2006
    Report Date
    September 13, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RESEARCH ARTICLE: RADIOFREQUENCY ENERGY IN HEPATIC BED DURING PARTIAL CYSTECTOMY FOR HYDATID LIVER DISEASE: STANDING OUT FROM THE USUAL CONSERVATIVE SURGICAL MANAGEMENT BACKGROUND. SURGICAL TREATMENT OF HYDATID LIVER DISEASE (HLD) IS DIVIDED INTO CONSERVATIVE AND RADICAL PROCEDURES. WHILE CONSERVATIVE TECHNIQUES ARE EASIER AND FASTER TO PERFORM, THERE IS AN EMERGING NEED TO REDUCE THEIR MORBIDITY AND RECURRENCE RATES. OUR AIM WAS TO PRESENT AND EVALUATE THE EFFICIENCY AND SAFETY OF THE APPLICATION OF RADIOFREQUENCY ENERGY (TISSUELINK AND AQUAMANTYS SYSTEMS) IN HEPATIC BED DURING PARTIAL CYSTECTOMY. MATERIALS AND METHODS. EIGHTEEN CONSECUTIVE PATIENTS WITH HYDATID LIVER CYSTS WERE REFERRED TO OUR DEPARTMENT BETWEEN APRIL 2006 AND JUNE 2014. DATA ABOUT DEMOGRAPHICS, MORTALITY, MORBIDITY, AND RECURRENCE RATE WERE OBTAINED AND ANALYZED RETROSPECTIVELY. RESULTS. THE MEAN FOLLOW-UP WAS 38 MONTHS (RANGE: 4-48 MONTHS). THE POSTOPERATIVE COURSE OF MOST PATIENTS WAS UNEVENTFUL. ONE CASE OF RECURRENCE WAS FOUND IN OUR SERIES IN A PATIENT WITH 4 CYSTS IN THE RIGHT LOBE, 3 YEARS AFTER INITIAL TREATMENT. HE WAS REOPERATED ON WITH THE SAME METHOD. CONCLUSIONS. SALINE-LINKED RF ENERGY SEEMS TO BE AN EFFECTIVE MEANS TO BE EMPLOYED IN CONSERVATIVE SURGICAL PROCEDURES OF HLD, WITH SATISFACTORY POSTOPERATIVE MORBIDITY. RECURRENCE RATES APPEAR TO BE LOW, BUT FURTHER FOLLOW-UP IS NEEDED IN ORDER TO DRAW SAFER CONCLUSIONS. ADVERSE EVENTS: ONE PATIENT (5.6%) WITH A LARGE CYST OF SECTORS VI,VII, VIII, AND IV DEVELOPED A LOW OUTPUT BILE FISTULA, WHICH RESOLVED AFTER 10 DAYS OF CONSERVATIVE TREATMENT. ONE PATIENT (5.6%) WITH A LARGE CYST OF THE RIGHT LOBE IN CONTACT WITH THE DIAPHRAGM DEVELOPED A RIGHT PLEURAL EFFUSION, WHICH WAS WITH PERCUTANEOUS DRAINAGE. THE MEAN FOLLOW-UP WAS 38 MONTHS (RANGE:4-84 MONTHS). NO PATIENT WAS LOST DURING THE FOLLOW-UP PERIOD. THREE OF THE PATIENTS HAD FEVER AS THE PRESENTING SYMPTOM AND FIVE HAD NONSPECIFIC ABDOMINAL SYMPTOMS. ALL ADVERSE EVENTS GROUPED INTO ONE EVENT DUE TO THE LACK OF UNIQUE PATIENT IDENTIFYING INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673923 MAE UNK AQM GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM GEN

    Patients

    Seq Age Sex Outcome Treatment
    1