BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PULSAR GENERATOR

    MDR report key: 7028642 · Received November 14, 2017

    Report

    Report Number
    1226420-2017-00291
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    August 1, 2012
    Report Date
    November 14, 2017
    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

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

    Description of Event or Problem · 1

    ARTICLE TITLE: COMPARISON OF ELECTROCAUTERY AND PLASMABLADE ON ISCHEMIA AND SEROMA FORMATION AFTER MODIFIED RADICAL MASTECTOMY FOR LOCALLY ADVANCED BREAST CANCER ABSTRACT: THE AIM OF THIS STUDY WAS TO COMPARE POSTOPERATIVE DRAINAGE VOLUMES AND IMA LEVELS IN PATIENTS WHO UNDERWENT MODIFIED RADICAL MASTECTOMY (MRM) WITH USING PLASMABLADE (PB) OR ELECTROCAUTERY (EC). A TOTAL OF 36 PATIENTS WHO UNDERWENT MRM WITH PB OR EC IN OUR CLINIC BETWEEN AUGUST 2012 TO FEBRUARY 2013 WERE ENROLLED. NUMBER OF REMOVED AND POSITIVE LYMPH NODES, DURATION OF DRAINAGE AND TOTAL DRAINAGE VOLUME WAS RECORDED. SEROMA FORMATION AFTER DRAIN REMOVAL AND NUMBER OF ASPIRATIONS WERE ALSO RECORDED. SERUM ISCHEMIA MODIFIED ALBÜMINE (IMA) LEVELS WERE ANALYSED BEFORE SURGERY, 1 HOUR AND 24 HOUR AFTER SURGERY. IN TOTAL, 36 PATIENTS WERE TREATED WITH MRM IN THE STUDY PERIOD. OF THE 36 PATIENTS, 16 UNDERWENT MRM WITH PB, AND 20 UNDERWENT MRM WITH EC. THE PATIENTS DEMOGRAPHICS WERE SIMILAR IN BOTH GROUPS. THE MEAN DRAINAGE VOLUME AND SEROMA FORMATION WERE SIGNIFICANTLY HIGHER IN THE PB GROUP WHEN COMPARED WITH EC GROUP (P<(><<)>0.05). NUMBER OF ASPIRATIONS DUE TO THE SEROMA WERE ALSO HIGH IN PB GROUP. THE TOTAL ASPIRATION VOLUME OF SEROMA WAS NOT DIFFERENT IN BOTH GROUPS. IMA LEVELS 24 HOURS AFTER SURGERY IN THE PB GROUP WAS SIGNIFICANTLY HIGHER THAN EC GROUP. THERE WAS NO STATISTICAL SIGNIFICANCE BETWEEN THE GROUPS FOR IMA LEVELS AT 1ST HOUR. PB IS A MONOPOLAR ENERGY DEVICE AND IS ASSOCIATED WITH INCREASED LEVELS OF ISCHEMIA. THIS SITUATION RESULTED WITH AN INCREASED VOLUME OF TOTAL AXILLARY DRAINAGE AND ELEVATED RISK OF SEROMA FORMATION. 16 PATIENTS UNDERWENT A MODIFIED RADICAL MASTECTOMY WITH THE PLASMABLADE DEVICE. ADVERSE EFFECTS REPORTED: - THE ISCHEMIA MODIFIED ALBUMIN (IMA) LEVELS TESTED STATISTICALLY HIGHER AFTER 24 HOURS WITH THE 16 PATIENTS IN THE PLASMABLADE GROUP WHEN COMPARED TO THE 20 PATIENTS IN THE ELECTROCAUTERY (EC) GROUP. - 4 PATIENTS DEVELOPED A SEROMA AND EXPERIENCED AN INCREASED NUMBER OF ASPIRATIONS WHEN COMPARED TO THE EC GROUP ALL PATIENTS ARE GROUPED INTO ONE EVENT DUE TO THE LACK OF UNIQUE PATIENT IDENTIFYING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810451 UNKNOWN PULSAR GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK PEAK GEN

    Patients

    Seq Age Sex Outcome Treatment
    1