BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS BIPOLAR SEALER

    MDR report key: 3943725 · Received July 18, 2014

    Report

    Report Number
    1226420-2014-00052
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT (B)(4). EVALUATION, METHOD, RESULT, CONCLUSION: DEVICES ASSOCIATED WITH ADVERSE EVENTS NOT RETURNED FOR ANALYSIS; THEREFORE, ANALYSIS UNABLE TO BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    AVERAGE AGE OF PATIENTS INVOLVED IN STUDY: 64.72 YEARS MAJORITY GENDER OF PATIENTS INVOLVED IN STUDY: FEMALE AVERAGE WEIGHT OF PATIENTS INVOLVED IN STUDY: UNDISCLOSED TITLE OF ARTICLE: USE OF A BIPOLAR SEALER IN TOTAL HIP ARTHROPLASTY: MEDICAL RESOURCE USE AND COSTS USING A HOSPITAL ADMINISTRATIVE DATABASE (DOI://10.3928/01477447-20140430-59) RETROSPECTIVE, COMPARATIVE COHORT STUDY IN THE US HOSPITAL SETTING TO ASSESS MEDICAL RESOURCE USE AND ASSOCIATED COSTS AND THE INCIDENCE OF TRANSFUSION AND COMPLICATIONS AMONG PATIENTS UNDERGOING THA WITH OR WITHOUT THE USE OF A BIPOLAR SEALER. THA PROCEDURES FROM JANUARY 1, 2008 - MARCH 31, 2011 (MEAN AGE 65 YEARS FROM 38 HOSPITALS) BIPOLAR COHORT: 2,683 NON-BIPOLAR COHORT: 2,683 RESULTS: SIMILAR INSTANCES OF PRE-OPERATIVE ANEMIA AND MEDICAL CO-MORBIDITIES. PATIENTS IN BIPOLAR SEALER GROUP HAD SIGNIFICANTLY FEWER BLOOD TRANSFUSIONS (21.3% VS. 23.8% P=.0286) SIGNIFICANTLY LOWER INCIDENCE OF HEMATOMAS (.2% VS. .9% P=.0015) SIGNIFICANTLY SHORTER LOS (2.90 VS. 3.31 DAYS P<(><<)>.0001) NO SIGNIFICANT DIFFERENCE IN FREQUENCY AND DURATION OF ICU STAYS (2.0% VS. 1.9% P=.20) TOTAL MEAN HOSPITAL COSTS WERE SIMILAR BETWEEN THE TWO COHORTS ($18,937 VS. $18,734 P=.56) DISCHARGE STATUS DIFFERED SIGNIFICANTLY (P<(><<)>.0001); MORE PATIENTS IN BIPOLAR SEALER GROUP WERE RELEASED TO HOME OR SELF-CARE (33.6% VS. 24.1%), FEWER TO HOME HEALTH ORGANIZATIONS (37.2% VS. 41.4%), OR SKILLED NURSING FACILITIES (23.6% VS. 26.8%) ADVERSE EVENTS REASONABLY RELATED TO USE OF BIPOLAR SEALER: BLOOD TRANSFUSIONS (571 INSTANCES) TRANSFUSION RELATED COMPLICATIONS (2 INSTANCES) POSTOPERATIVE INFECTIONS (97 INSTANCES) SUBSEQUENT NON-ELECTIVE HOSPITALIZATIONS (9 INSTANCES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421937 AQUAMANTYS BIPOLAR SEALER ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR