BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9652623 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00638
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 2, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    TITLE : ROBOTIC MAJOR LIVER RESECTIONS ANALYSIS OF TECHNIQUE AND INTRAOPERATIVE HEMODYNAMICS. AUTHOR : DAVID CALATAYUD, MD PHD, STEFANO D¿UGO, MD, FRANCESCO CORATTI, MD, PAOLO RAIMONDI, MD, FEDERICO GHEZA, MD, MARIO MASRUR, MD, ENRIQUE F ELLI, MD, FRANCESCO M BIANCO, MD, SUBASHINI AYLOO, MD, PIER C GIULIANOTTI, MD FACS. CITATION: SURG ENDOSC (2012) 26:S249¿S430. DOI 10.1007/S00464-012-2203-X. THE OBJECTIVE OF THIS STUDY WAS TO PRESENT A SERIES OF MAJOR LIVER RESECTIONS PERFORMED BY THE ROBOTIC APPROACH, FOCUSING IN THE INTRAOPERATIVE DATA CONCERNING THE TECHNICAL SURGICAL ASPECTS, AS WELL AS THE HEMODYNAMIC MANAGEMENT. THERE WERE 47 PATIENTS (MALE/FEMALE: 24/23) WHO UNDERWENT MAJOR LIVER RESECTIONS FROM NOVEMBER 2003 TO JULY 2011 PERFORMED IN 3 DIFFERENT CENTERS. THE MEAN AGE OF THE PATIENTS WAS 57.01 ± 14.98 (SD), WITH A MEAN BMI OF 27.63 KG/M2 ± 6.8. THE HARMONIC SCALPEL WAS THE DEVICE MOST FREQUENTLY USED DURING THE PARENCHYMAL TRANSECTION (95.7% OF THE CASES). POSTOPERATIVE BILE LEAK WAS REPORTED IN 1 PATIENT AND WAS TREATED ENDOSCOPICALLY WITH AN ERCP. IN CONCLUSION, THE AUTHORS REPORTED THAT ROBOT ASSISTED MAJOR LIVER RESECTIONS SEEM TO BE FEASIBLE AND TO HAVE GOOD OUTCOMES. THE ROBOTIC TECHNOLOGY COULD EXPAND THE ROLE OF THE MINIMALLY INVASIVE APPROACH IN HEPATOBILIARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113999 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention