BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 3223570 · Received July 12, 2013

    Report

    Report Number
    1226420-2013-00129
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    October 1, 2009
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODE METHOD: DEVICE NOT RETURNED THEREFORE ANALYSIS UNABLE TO BE PERFORMED. EVALUATION RESULT, CONCLUSION: DEVICE NOT RETURNED THEREFORE ANALYSIS UNABLE TO BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    OBJECTIVE OF THE STUDY WAS TO ASSESS THE EFFECTIVENESS OF THE BIPOLAR SEALER WHEN COMPARED TO THE STANDARD ELECTROCAUTERY DEVICE IN TERMS OF MINIMIZING BLOOD LOSS AND PRESERVING PATIENT HEMOGLOBIN. A REDUCED NEED TO TRANSFUSE BLOOD COULD MINIMIZE PATIENT RISK RELATED TO BLOOD TRANSFUSION AND ULTIMATELY REDUCE HOSPITAL LENGTH OF STAY. THIS STUDY: 30 TREATED WITH BIPOLAR SEALER 90 TREATED WITH STANDARD ELECTROCAUTERY 10% OF PARTICIPANTS REQUIRED BLOOD TRANSFUSION POSTOPERATIVELY; 25% (3 PATIENTS) TREATED WITH BIPOLAR SEALER, 75% (9 PATIENTS) TREATED WITH STANDARD ELECTROCAUTERY. 3/120=2.5% RATE OF TRANSFUSION WITH USE OF BIPOLAR SEALER NO SIGNIFICANT INCIDENCE OF BLOOD TRANSFUSION IN EITHER GROUP NO SIGNIFICANT DIFFERENCE IN MEAN HEMOGLOBIN PREOPERATIVELY OR AT DAY 1, 2, OR 3 POSTOPERATIVELY IIN EITHER GROUP NO SIGNIFICANT DIFFERENCE IN LENGTH OF HOSPITAL STAY IN EITHER GROUP DUE TO THE NEED FOR PATIENT TRANSFUSIONS THIS INCIDENT IS DEEMED REPORTABLE. NO PATIENT IDENTIFYING INFORMATION THEREFORE 3 TRANSFUSIONS REPORTED ON THIS 1 MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323519 AQUAMANTYS 6.0 BIPOLAR SEALER ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC 23-112-1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1