BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9652513 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00631
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. 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: INTRAOPERATIVE AND POSTOPERATIVE OUTCOME OF ROBOT-ASSISTED AND TRADITIONAL LAPAROSCOPIC NISSEN FUNDOPLICATION. AUTHOR/S: G. CECCARELLI A. PATRITI A. BIANCAFARINA A. SPAZIANI A. BARTOLI R. BELLOCHI L. CASCIOLA. CITATION: EUR SURG RES 2009;43:198¿203; DOI: 10.1159/000223751. THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE OUTCOME OF CONVENTIONAL LAPAROSCOPIC FUNDOPLICATION (CLF) AND LAPAROSCOPIC ROBOT-ASSISTED FUNDOPLICATION (LRF) IN TWO LARGE GROUPS OF UNSELECTED PATIENTS UNDERGOING SURGERY AFTER COMPLETION OF THE SURGERY LEARNING CURVE. BETWEEN OCTOBER 1993 AND SEPTEMBER 2007, MINIMALLY INVASIVE OPERATION WAS PROPOSED TO ALL PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD) SCHEDULED FOR SURGERY. 137 PATIENTS (MEAN AGE 54 (26-76) YEARS, MALE/FEMALE RATIO 0.8) UNDERWENT CLF FROM 1993 TO 2002 AND 45 PATIENTS (MEAN AGE 55 (29-76) YEARS, MALE/FEMALE RATIO 1.1) UNDERWENT LRF FROM NOVEMBER 2002 TO OCTOBER 2007. FOR THE CONVENTIONAL LAPAROSCOPIC FUNDOPLICATION, AFTER LEFT LIVER LOBE RETRACTION BY A 5-FINGER FAN RETRACTOR, THE HIATAL PILLARS WERE FULLY EXPOSED BOTH ANTERIOLATERAL AND POSTERIOR TO THE LOWER ESOPHAGUS USING A HARMONIC SCALPEL (ULTRACISION; ETHICON ENDO-SURGERY, JOHNSON-JOHNSON COMPANY, PRATICA DI MARE, ITALY) OR HOOK CAUTERY. DISSECTION WAS THEN CARRIED OUT OVER TO THE CRURA, OPENING THE GASTROHEPATIC LIGAMENT AND PRESERVING THE ABERRANT LEFT HEPATIC ARTERY AND THE HEPATIC BRANCH OF THE VAGUS NERVE. THE RETROESOPHAGEAL SPACE WAS DISSECTED AND A WINDOW WAS CREATED BEHIND THE ESOPHAGUS USING THE CURVED GRASPER ENDOFLEX (ETHICON INC., SOMERVILLE, N.J., USA). COMPLICATIONS INCLUDED LEFT LIVER LOBE TEAR (N=5), GASTRIC PERFORATION (N=1), PNEUMOTHORAX (N=1), SPLEEN INJURY (N=1) AND DIARRHEA (N=2). IN CONCLUSION, ROBOTICS IMPROVES SURGEON DEXTERITY AND MANEUVERABILITY DURING LAPAROSCOPIC NISSEN FUNDOPLICATION, BUT THIS DOES NOT CORRESPOND TO A BETTER POSTOPERATIVE OUTCOME. LRF SHOULD BE USED ONLY FOR COMPLEX CASES AND TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116621 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other