BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAE UNKNOWN AQUAMANTYS DEVICE

    MDR report key: 3778269 · Received April 29, 2014

    Report

    Report Number
    1226420-2014-00034
    Event Type
    Death
    Date Received
    April 29, 2014
    Date of Event
    June 1, 2010
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD, RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. (B)(4).

    Description of Event or Problem · 1

    EVENT DATE: (B)(6) 2010 (DATE THAT STUDY PERIOD STOPPED) AIM OF THE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO DEVICE COMBINATIONS (TISSUELINK/CUSA, TISSUELINK/HARMONIC SCALPEL) USED IN PARENCHYMAL DIVISION DURING HEPATIC RESECTION IN NO-CIRRHOTIC PATIENTS AND WITHOUT INFLOW VASCULAR OCCLUSION. RETROSPECTIVELY ANALYZED 47 PATIENTS WHO UNDERWENT LIVER RESECTION FROM 2004-2010: TISSUELINK/CUSA, 27 PATIENTS; TISSUELINK/HARMONIC SCALPEL, 20 PATIENTS (ALL SURGERIES PERFORMED BY SAME SURGEON) COMPLICATIONS (TISSUELINK/CUSA): 7 COMPLICATIONS GRADE II: 1 DVT, 1 PNEUMONIA GRADE III: 3 BILE LEAKS, 1 GI BLEED GRADE V: 1 DEATH (MASSIVE MYOCARDIAL INFARCTION) COMPLICATIONS (TISSUELINK/HARMONIC SCALPEL): 4 COMPLICATIONS GRADE II: 1 PNEUMONIA GRADE III: 1 BILE LEAK, 1 INTRA-ABDOMINAL ABSCESS GRADE V: 1 DEATH (MULTI-SYSTEM ORGAN FAILURE SECONDARY TO CMV INFECTION) ALL COMPLICATIONS GROUPED TOGETHER AS THERE NO PATIENT IDENTIFYING INFORMATION WAS WILLING TO BE GIVEN BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256846 MAE UNKNOWN AQUAMANTYS DEVICE ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1