BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AQUAMANTYS DEVICE

    MDR report key: 6394664 · Received March 10, 2017

    Report

    Report Number
    1226420-2017-00104
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    January 1, 2010
    Report Date
    February 10, 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)(6). PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. . A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ARTICLE TITLE: USE OF A SALINE-COUPLED BIPOLAR SEALER OPEN LIVER RESECTION FOR HEPATIC MALIGNANCY: MEDICAL RESOURCE USE AND COSTS DOI: 10.3748/WJG.V22.I46.10189 AIM TO EVALUATE OUTCOMES ASSOCIATED WITH USE OF A SALINE COUPLED BIPOLAR SEALER DURING OPEN PARTIAL LIVER RESECTION. METHODS THIS RETROSPECTIVE ANALYSIS UTILIZED THE UNITED STATES PREMIER¿ INSURANCE CLAIMS DATABASE (2010-2014). PATIENTS WERE SELECTED WITH CODES FOR LIVER MALIGNANCY AND PARTIAL HEPATECTOMY OR LOBECTOMY. CASES WERE DEFINED BY USE THE SALINE-COUPLED BIPOLAR SEALER; CONTROLS HAD NO USE. A PROPENSITY SCORE ALGORITHM WAS USED TO MATCH ONE CASE TO FIVE CONTROLS. A DEVIATION BASED COST MODELING (DBCM) APPROACH PROVIDED AN ESTIMATE OF COST-EFFECTIVENESS. RESULTS ONE HUNDRED AND FORTY-FOUR CASES AND 720 CONTROLS WERE AVAILABLE FOR ANALYSIS. PATIENTS IN THE CASE COHORT RECEIVED FEWER TRANSFUSIONS VS CONTROLS (18.1% VS 29.4%, P = 0.007). IN DBCM, MORE PATIENTS IN THE CASE COHORT EXPERIENCED ¿ON-COURSE¿ HOSPITALIZATIONS (53.5% VS 41.9%, P = 0.009). THE COST CALCULATION SHOWED AN AVERAGE SAVINGS IN TOTAL HOSPITALIZATION COSTS OF $1027 FOR CASES VS CONTROLS. IN MULTIVARIATE ANALYSIS, CASES HAD LOWER ODDS OF RECEIVING A TRANSFUSION (OR = 0.44, 95%CI: 0.27-0.71, P = 0.0008). CONCLUSION USE OF A SALINE-COUPLED BIPOLAR SEALER WAS ASSOCIATED WITH A GREATER PROPORTION OF PATIENTS WITH AN ¿ON COURSE¿ HOSPITALIZATION. THIS RECORD REPRESENTS THE PATIENT THAT EXPERIENCE A BILE LEAK POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177594 UNKNOWN AQUAMANTYS DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR