BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONO DISSECTING SEALER DS3.0

    MDR report key: 5060868 · Received September 8, 2015

    Report

    Report Number
    1226420-2015-00150
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    May 11, 2015
    Report Date
    August 10, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K014260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT # (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LIVER RESECTION USING CAVITRON ULTRA SURGICAL ASPIRATION (CUSA) VERSUS HARMONIC SCALPEL: A RETROSPECTIVE COHORT STUDY ADAM S. BODZIN, BENJAMIN E. LEIBY, CARLO G. RAMIREZ, ADAM M. FRANK, CATALDO DORIA INTERNATIONAL JOURNAL OF SURGERY (2014) ISSUE #12 DX.DOI.ORG/10.1016/J.IJSU.2014.02.007 THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF TWO DEVICE COMBINATIONS USED IN PARENCHYMAL DIVISION DURING HEPATIC RESECTIONS IN NON-CIRRHOTIC PATIENTS AND WITHOUT INFLOW VASCULAR OCCLUSION. WE RETROSPECTIVELY ANALYZED 47 PATIENTS WHO UNDERWENT LIVER RESECTION AT OUR INSTITUTION FROM 2004 TO 2010 USING THE TISSUELINK WITH EITHER THE CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA) OR THE HARMONIC SCALPEL. THE TISSUELINK WAS USED WITH THE CUSA IN 27 PATIENTS AND WITH THE HARMONIC SCALPEL IN 20 PATIENTS. THERE WERE 7 TOTAL PERIOPERATIVE COMPLICATIONS DOCUMENTED IN THE CUSA/TISSUELINK GROUP WHICH INCLUDED TWO CLAVIEN-DINDO GRADE II COM PLICATIONS: 1 DEEP VENOUS THROMBOSIS, 1 PNEUMONIA; FOUR CLAVIEN-DINDO GRADE III COMPLICATIONS: 3 BILE LEAKS, 1 GASTROINTESTINAL BLEED; AND ONE CLAVIEN-DINDO GRADE V COMPLICATION: INTRAOPERATIVE DEATH DUE TO MASSIVE MYOCARDIAL INFARCTION. THERE WERE 4 COMPLICATIONS SEEN IN THE HARMONIC SCALPEL/TISSUE-LINK GROUP INCLUDING ONE CLAVIEN-DINDO GRADE II COMPLICATION: 1 PNEUMONIA; TWO CLAVIEN-DINDO GRADE III COMPLICATIONS: 1 BILE LEAK, 1 INTRA-ABDOMINAL ABSCESS; AND ONE CLAVIEN-DINDO GRADE V COMPLICATION: 1 PERIOPERATIVE DEATH DUE TO MULTI-SYSTEM ORGAN FAILURE SECONDARY TO CMV INFECTION. NO UNIQUE PATIENT INFORMATION THEREFORE ALL PATIENT OUTCOMES WILL BE REPORTED IN ONE MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592733 MONO DISSECTING SEALER DS3.0 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 13-101-1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1