BEUDAMED
    FDA Adverse Event Death Summary report: N

    GENERATOR 40-402-1 AQM 115V

    MDR report key: 5687007 · Received May 27, 2016

    Report

    Report Number
    1226420-2016-00061
    Event Type
    Death
    Date Received
    May 27, 2016
    Date of Event
    November 25, 2014
    Report Date
    April 29, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (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

    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.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: COMBINED ULTRASONIC ASPIRATION AND SALINE-LINKED RADIOFREQUENCY PRECOAGULATION: A STEP TOWARD BLOODLESS LIVER RESECTION WITHOUT THE NEED OF LIVER INFLOW OCCLUSION: ANALYSIS OF 313 CONSECUTIVE PATIENTS 313 PATIENTS UNDERWENT A LIVER RESECTION. THERE WERE 2 POSTOPERATIVE DEATHS (0.6%) AND 84 (26.8%) PATIENTS REPORTED TO EXPERIENCE ADVERSE EVENTS. COMPLICATIONS: 119 COMPLICATIONS IN 84 PATIENTS (26.8%) 21 PATIENTS (6.7%) HAD MAJOR COMPLICATIONS, GRADE 3 AND 4 PLEURAL EFFUSION: MAJOR (23), MINOR (25) BILE LEAK: MAJOR (9), MINOR (7) WOUND INFECTION: MAJOR (27), MINOR (12) INTRAABDOMINAL HEMORRHAGE: MAJOR (2), MINOR (2) DVT: MAJOR (4), MINOR (3) INTRAABDOMINAL COLLECTION: MAJOR (8), MINOR (6) TRANSIENT HEPATIC FAILURE: MAJOR (6) THIRTY-DAY MORTALITY: MAJOR (1), MINOR (1) MORTALITY: 0.63% (2 DEATHS POST-OPERATIVELY) PE CAUSED BY DVT, LIVER FAILURE ALL ADVERSE EVENTS GROUPED INTO ONE EVENT DUE TO THE LACK OF UNIQUE PATIENT IDENTIFYING INFORMATION. DOI: 10.1186/1477-7819-12-357.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339506 GENERATOR 40-402-1 AQM 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 40-402-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R