BEUDAMED
    FDA Adverse Event Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 3233576 · Received July 18, 2013

    Report

    Report Number
    1226420-2013-00133
    Date Received
    July 18, 2013
    Date of Event
    September 9, 2012
    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

    PRODUCT EVENT: (B)(4). EVALUATION METHOD: DEVICES INVOLVED DISPOSED OF BY CUSTOMER; THEREFORE, PRODUCT ANALYSIS UNABLE TO BE PERFORMED. EVALUATION CODE RESULT: DEVICES INVOLVED DISPOSED OF BY CUSTOMER; THEREFORE, PRODUCT ANALYSIS UNABLE TO BE PERFORMED. EVALUATION CODE CONCLUSION: DEVICES INVOLVED DISPOSED OF BY CUSTOMER;R THEREFORE. PRODUCT ANALYSIS UNABLE TO BE PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT DATA REPRESENTS THE AVERAGE OF ALL PATIENTS INVOLVED IN TREATMENT ARM OF STUDY. 9/9/2012 (DATE ARTICLE RECEIVED FOR PUBLISHMENT) EVENT DATE NOT SPECIFIED IN ARTICLE (HTTP://DX.DOI.ORG/10.1016/J.ARTH.2013.01.032) TWO HUNDRED CONSECUTIVE PATIENTS UNDERGOING PRIMARY UNILATERAL TOTAL HIP ARTHROPLASTY THROUGH THE ANTERIOR SUPINE INTERMUSCULAR APPROACH WERE ENROLLED IN THIS STUDY. PATIENTS WERE RANDOMIZED TO EITHER THE TREATMENT ARM (UTILIZATION OF THE AQUAMANTYS 6.0 BIPOLAR SEALER [SALIENT SURGICAL TECHNOLOGIES, PORTSMOUTH, NEW HAMPSHIRE] OR THE CONTROL ARM (STANDARD MONOPOLAR ELECTROCAUTERY). VARIABLES ANALYZED IN ASSESSING THE EFFECTIVENESS OF THE BIPOLAR SEALER INCLUDED: ESTIMATED BLOOD LOSS, REQUIRED TRANSFUSIONS, POSTOPERATIVE DAY 1 HEMOGLOBIN, AND WOUND HEALING 6 WEEKS POSTOPERATIVELY. DIFFERENCE IN BLOOD LOSS WAS FOUND TO BE STATISTICALLY SIGNIFICANT BETWEEN THE TWO GROUPS (P=0.0344), WITH THE TREATMENT GROUP HAVING MORE INTRAOPERATIVE BLOOD LOSS THAN THE CONTROL, WITH MEAN BLOOD LOSS OF 140.8 AND 127.5, RESPECTIVELY. THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE REQUIRED TRANSFUSIONS, POSTOPERATIVE DAY 1 HEMOGLOBIN, OR WOUND HEALING. IT WAS ALSO NOTED THAT 6 PATIENTS IN THE TREATMENT GROUP REQUIRED TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335653 AQUAMANTYS 6.0 BIPOLAR SEALER ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC 23-112-1 UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR