BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAE UNKNOWN AQUAMANTYS DEVICE

    MDR report key: 5687026 · Received May 27, 2016

    Report

    Report Number
    1226420-2016-00062
    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
    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.

    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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341268 MAE UNKNOWN AQUAMANTYS DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R