BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9439145 · Received December 9, 2019

    Report

    Report Number
    3005075853-2019-24104
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    January 1, 2016
    Report Date
    November 15, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: PUBLICATION YEAR OF 2016. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE(S) CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: ROBOTIC VERSUS LAPAROSCOPIC RIGHT COLECTOMY FOR COLON CANCER: ANALYSIS OF THE INITIAL SIMULTANEOUS LEARNING CURVE OF A SURGICAL FELLOW. AUTHOR : NICOLA DE¿ANGELIS, MD, PHD, VINCENZO LIZZI, MD, DANIEL AZOULAY, MD, PHD, AND FRANCESCO BRUNETTI, MD. AUTHORS: NICOLA DE¿ANGELIS, MD, PHD; VINCENZO LIZZI, MD; DANIEL AZOULAY, MD, PHD; AND FRANCESCO BRUNETTI, MD. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES VOLUME 26, NUMBER 11, 2016; DOI: 10.1089/LAP.2016.0321. THIS PROSPECTIVE STUDY AIMED TO COMPARE THE LEARNING CURVE OF ROBOTIC-ASSISTED RIGHT COLECTOMY (RRC) VERSUS LAPAROSCOPIC-ASSISTED RIGHT COLECTOMY (LRC) FOR COLON CANCER WITH RESPECT TO OPERATIVE TIMES AND PERIOPERATIVE OUTCOMES. BETWEEN NOVEMBER 2012 AND DECEMBER 2015, 50 PATIENTS (FEMALE=31, MALE=19; MEAN AGE=71.1 ± 12.92 YEARS; BMI=25.26 ± 4.19 KG/M^2) UNDERWENT LRC AND 30 PATIENTS (FEMALE=15, MALE=15; MEAN AGE=71 ± 8.50 YEARS; BMI=26.43 ± 3.21 KG/M^2) UNDERWENT RRC, FOR COLON CANCER. DURING THE PROCEDURE OF LRC, THE INFERIOR SIDE OF THE DUODENUM, AN INCISION OVER THE PERITONEUM WAS MADE WITH A HARMONIC ACE (ETHICON). FOR CANCER OF THE CECUM, THE ILEOCOLIC AND RIGHT BRANCHES OF THE MIDDLE COLIC VESSELS WERE CLIPPED PROXIMALLY AND ON THE SPECIMEN SIDE AND DIVIDED WITH THE HARMONIC ACE. THE MESENTERY WAS DIVIDED COMPLETELY FROM COLON TO CECUM WITH THE HARMONIC ACE. EXTRACORPOREAL SIDE-TO-SIDE ANASTOMOSES WERE CARRIED OUT USING LINEAR STAPLERS (ETHICON). REPORTED COMPLICATIONS IN LRC GROUP INCLUDED TECHNICAL DIFFICULTIES RELATED TO BLEEDING DURING RIGHT COLIC ARTERY DISSECTION AND INADEQUATE VIEWS (N=2), WHICH THE PATIENTS WERE CONVERTED TO LAPAROTOMY; ANASTOMOTIC LEAKAGE (N=2) WHICH THEY WERE CLASSIFIED AS DINDO-CLAVIEN GRADE IV AND THE PATIENTS UNDERWENT REOPERATION (ONE BY LAPAROSCOPY AND ONE BY LAPAROTOMY), THEN BOTH PATIENTS UNDERWENT STROMA DIVERSION AND PERITONEAL LAVAGE; INTRAABDOMINAL ABSCESS (N=1). IN CONCLUSION, BOTH ROBOTIC AND LAPAROSCOPIC OPERATIVE TIMES DECREASE RAPIDLY WITH PRACTICE. HOWEVER, RRC IS ASSOCIATED WITH A FASTER LEARNING CURVE THAN LRC. THE SIMULTANEOUS DEVELOPMENT OF THESE TWO MINIMALLY INVASIVE APPROACHES APPEARS TO BE SAFE AND FEASIBLE WITH ACCEPTABLE HEALTH-RELATED COSTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230036 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention