BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM EXACT CODE UNKNOWN

    MDR report key: 7727819 · Received July 27, 2018

    Report

    Report Number
    3005075853-2018-11620
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    January 1, 2009
    Report Date
    June 29, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: ROBOT-ASSISTED VERSUS LAPAROSCOPIC RECTAL RESECTION FOR CANCER IN A SINGLE. SURGEON¿S EXPERIENCE: A COST ANALYSIS COVERING THE INITIAL 50 ROBOTIC CASES WITH THE DA VINCI SI. AUTHORS: LUCA MORELLI, SIMONE GUADAGNI, VALENTINA LORENZONI, GREGORIO DI FRANCO, LUIGI COBUCCIO, MATTEO PALMERI, GIOVANNI CAPRILI, CRISTIANO D¿ISIDORO, ANDREA MOGLIA, VINCENZO FERRARI, GIULIO DI CANDIO, FRANCO MOSCA, AND GIUSEPPE TURCHETTI. CITATION: INT J COLORECTAL DIS (2016) 31:1639¿1648; DOI 10.1007/S00384-016-2631-5; PUBLISHED ONLINE: 31 JULY 2016. THE AIM OF THIS RETROSPECTIVE COMPARATIVE STUDY WAS TO COMPARE SURGICAL PARAMETERS AND THE COSTS OF ROBOTIC SURGERY WITH THOSE OF LAPAROSCOPIC APPROACH IN RECTAL CANCER BASED ON A SINGLE SURGEON¿S EARLY ROBOTIC EXPERIENCE. BETWEEN THE PERIODS FROM JANUARY 2009 TO DECEMBER 2014, 75 PATIENTS WHO UNDERWENT MINIMALLY INVASIVE RECTAL RESECTION WITH TOTAL MESORECTAL EXCISION (TME). THE FIRST CONSECUTIVE 50 ROBOTIC RECTAL RESECTIONS (ROBTME) WERE COMPARED WITH 25 LAPAROSCOPIC RECTAL RESECTIONS (LAPTME) PERFORMED WITHIN THE SAME PERIOD BY THE SAME EXPERIENCED LAPAROSCOPIC SURGEON. IN THE LAPTME, THE DISSECTION AND COAGULATION WERE ALWAYS PERFORMED USING ULTRACISION® HARMONIC SCALPEL (ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA). DURING THE PROCEDURE IN THE ROBTME TECHNIQUE, THE DISSECTION CONTINUED ANTERIORLY AND THEN LATERALLY DOWN TO LEVATOR ANI PLANE. THE RECTUM WAS DIVIDED WITH THE ECHELON FLEX¿ 60-MM STAPLER (ETHICON, CINCINNATI, OH, USA). THE COLON RESECTION WAS COMPLETED THROUGH A PFANNENSTIEL SUPRAPUBIC MINI-LAPAROTOMY. THE ANASTOMOSIS WAS PERFORMED WITH A CDH29 CIRCULAR STAPLER (ETHICON, CINCINNATI, OH, USA) INSERTED TRANS-ANALLY, ACCORDING TO THE KNIGHT¿GRIFFIN TECHNIQUE. THERE WERE 4 PATIENTS IN THE ROBTME GROUP (P > 0.5) EXPERIENCED TRANSIENT SMALL BOWEL OBSTRUCTION, WHICH RESOLVED WITH INSERTION OF A 24-F FOLEY CATHETER IN THE ILEOSTOMY. ANASTOMOTIC LEAK/PELVIC ABSCESS WERE REPORTED FOR 6 PATIENTS. PELVIC ABSCESS REQUIRED SURGICAL TREATMENT. THERE WERE 2 PATIENTS IN THE ROBTME GROUP DEVELOPED WOUND INFECTIONS (SUPERFICIAL SURGICAL SITE INFECTION) THAT RESOLVED WITH MEDICAL TREATMENT. MEDICAL COMPLICATIONS WERE OBSERVED FOUR IN THE ROBTME GROUP (THREE CASES OF GRADE III AND ONE CASE OF GRADE V ACCORDING TO THE CLAVIEN¿DINDO CLASSIFICATION) (P > 0.5). IN CONCLUSION, OUR RESULTS SUGGEST A SIGNIFICANT OPTIMIZATION OF ROBOTIC RECTAL SURGERY¿S COSTS WITH EXPERIENCE. EFFORTS TO REDUCE THE DOMINANT FIXED COST ARE RECOMMENDED TO MAINTAIN THE SUSTAINABILITY OF THE SYSTEM AND BENEFIT FROM THE TECHNICAL ADVANTAGES OFFERED BY THE ROBOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567317 PWRD ECH FLEX 60MM EXACT CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1