BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 12675516 · Received October 21, 2021

    Report

    Report Number
    3005075853-2021-06344
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    May 17, 2020
    Report Date
    October 21, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 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 CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: THE PATIENT-SIDE SURGEON PLAYS A KEY ROLE IN FACILITATING ROBOT-ASSISTED INTRACORPOREAL ILEAL CONDUIT URINARY DIVERSION IN MEN AUTHOR/S: YUTARO SASAKI · MASAYUKI TAKAHASHI · KYOTARO FUKUTA · KEITO SHIOZAKI · KEI DAIZUMOTO · KEISUKE OZAKI · YOSHITERU UENO · MEGUMI TSUDA · YOSHITO KUSUHARA · TOMOYA FUKAWA1 · YASUYO YAMAMOTO · KUNIHISA YAMAGUCHI · HIROFUMI IZAKI · KAZUYA KANDA · HIROOMI KANAYAMA CITATION: JOURNAL OF ROBOTIC SURGERY HTTPS://DOI.ORG/10.1007/S11701-021-01256-X THIS STUDY AIMED TO DESCRIBE THE SURGICAL TECHNIQUES OF THE PATIENT-SIDE SURGEON (PSS) IN ROBOT-ASSISTED RADICAL CYSTECTOMY (RARC) AND INTRACORPOREAL ILEAL CONDUIT (ICIC) URINARY DIVERSION AND OBJECTIVELY EXAMINE THE CHANGES IN SURGICAL OUTCOMES WITH INCREASING PSS EXPERIENCE. FROM JANUARY 2018 TO DECEMBER 2020, A TOTAL OF 28 MEN UNDERWENT RARC AND ICIC URINARY DIVERSION. THE MEDIAN AGE WAS 76 YEARS AND THE MEDIAN BMI WAS 22.9 KG/M2. NONE OF THE BASELINE VARIABLES SIGNIFICANTLY DIFFERED BETWEEN THE TWO GROUPS. AFTER THE CYSTOPROSTATECTOMY SPECIMEN WAS REMOVED, THE MINIMAL WOUND WAS USED FOR ICUD USING THE GLOVE PORT TECHNIQUE. A RETRACTOR (ALEXIS WOUND RETRACTOR XS; APPLIED MEDICAL, RANCHO SANTA MARGARITA, CA, USA) WAS ATTACHED TO THE MINIMAL WOUND AND USED FOR ICUD AS A 12-MM PORT USING SURGICAL GLOVES. AT THIS POINT, THE ROBOT WAS RE-DOCKED WITH THE PATIENT IN THE 10-DEGREE TRENDELENBURG TILT POSITION AND ICUD WAS PERFORMED. FOR ILEAL ISOLATION AND ANASTOMOSIS, THE PSS OPERATED AN AUTOMATIC ANASTOMOSIS DEVICE (POWERED ECHELON FLEX, SUTURE LENGTH 60 MM; ETHICON, SOMERVILLE, NJ, USA) THROUGH THE GLOVE PORT. DUE TO THE SMALL WORKING SPACE OF A NORMAL PORT, THE HINGE OF THE AUTOMATIC ANASTOMOSIS DEVICE CANNOT REACH THE ABDOMINAL CAVITY, MAKING THIS PROCEDURE DIFFICULT. IN CONTRAST, USING THE GLOVE PORT WIDENS THE WORKING SPACE, MAKING THIS OPERATION EASIER. AFTER ILEAL ISOLATION AND ANASTOMOSIS, URETERO-ILEAL ANASTOMOSIS WAS PERFORMED. ONCE THE POSTERIOR WALL WAS ANASTOMOSED, URETERAL STENTS WERE PASSED INTO THE URETERAL END TOWARD THE RENAL PELVIS. AT OUR FACILITY, THE PSS USES A SUCTION TIP AND STAY SUTURE TECHNIQUE TO RETROGRADELY PASS A URETERAL STENT THROUGH THE ILEAL CONDUIT. THE MESENTERY WAS FIRST LIGATED ON THE DISTAL PART OF THE CONDUIT WITH 3¿0 ABSORBABLE BRAIDED SUTURE (ETHICON 3¿0 VICRYL SH), AND THE SUTURE WAS GUIDED OUT OF THE BODY THROUGH THE 5-MM PORT IN THE UPPER RIGHT ABDOMEN AND USED AS A STAY SUTURE. THE SUCTION TIP WAS RETROGRADELY PASSED THROUGH THE ILEAL CONDUIT VIA THE 5-MM PORT. AT THIS TIME, THE PSS PULLED THE STAY SUTURE AND THE CS PULLED THE PROXIMAL PORTION OF THE CONDUIT TO STRAIGHTEN THE CONDUIT, FACILITATING THE PASSAGE OF THE SUCTION TIP. AFTER THE SUCTION TIP HAD PASSED THROUGH THE ILEAL CONDUIT, THE PSS ADVANCED THE URETERAL STENT AND GUIDEWIRE THROUGH THE SUCTION TIP, AND THE CS RETROGRADELY INSERTED THE URETERAL STENT INTO THE URETERAL END TOWARD THE KIDNEY. AFTER THE ROBOT SURGERY WAS COMPLETED, A STOMA WAS CREATED. THE PRE-DOCKING INCISION ALLOWED THE PSS TO SEAMLESSLY CREATE THE STOMA. THE SKIN AND UNDERLYING FAT TISSUE HAD ALREADY BEEN REMOVED, SO THE SURGEON ACCESSED THE ABDOMINAL CAVITY SIMPLY BY INCISING THE FASCIA. AT THIS TIME, A STOMA WAS CREATED WITH THE ROBOT STILL DOCKED. BECAUSE THE ABDOMINAL WALL HAD BEEN LIFTED BY THE ROBOT ARM, THE SURGICAL FIELD WAS MAINTAINED EVEN AFTER THE ABDOMINAL CAVITY WAS OPENED AND THE PNEUMOPERITONEUM PRESSURE DISAPPEARED, SO THAT FASCIA COULD BE SUTURED AND THE DISTAL PORTION OF THE ILEAL CONDUIT WAS EASILY PULLED UP. TO AVOID PARASTOMAL HERNIA, THE FASCIA WAS SUTURED WITH 2¿0 ABSORBABLE BRAIDED SUTURE (2¿0 VICRYL UR-6; ETHICON, SOMERVILLE, NJ, USA) AT EIGHT POINTS IN ADVANCE. AFTER THAT, THE STAY SUTURE OF THE DISTAL PART OF THE CONDUIT WAS USED TO PULL IT THROUGH THE ABDOMINAL WALL. THE ROBOT WAS THEN UNDOCKED. THE INCIDENCE OF COMPLICATIONS OF ALL GRADES WITHIN THE FIRST 30 DAYS POSTOPERATIVELY WAS 28.6%. THREE PATIENTS IN THE FIRST HALF GROUP HAD MAJOR COMPLICATIONS, INCLUDING AN INFECTED LYMPHOCELE THAT REQUIRED PERCUTANEOUS DRAINAGE IN TWO PATIENTS AND A CONDUIT-ENTERIC FISTULA REQUIRING FISTULA CLOSURE SURGERY IN ONE PATIENT. IN THE SECOND HALF GROUP, FOUR PATIENTS HAD MINOR COMPLICATIONS 2 UTI TREATED WITH ANTIBIOTICS IN TWO PATIENTS, AND ILEUS TREATED CONSERVATIVELY IN TWO PATIENTS AND ONE HAD A MAJOR COMPLICATION (PANPERITONITIS DUE TO RECTAL INJURY THAT REQUIRED A TEMPORARY COLOSTOMY). THE INCIDENCE OF COMPLICATIONS OF ALL GRADES 30¿90 DAYS POSTOPERATIVELY WAS 7.1%. NO MAJOR COMPLICATIONS WERE OBSERVED 30¿90 DAYS AFTER SURGERY, AND ALL MAJOR COMPLICATIONS OCCURRED WITHIN 30 DAYS AFTER SURGERY. NO COMPLICATIONS OCCURRED DUE TO THE PSS SURGICAL TECHNIQUES. REPORTED COMPLICATIONS INCLUDED N=3 INFECTED LYMPHOCELE, N=1 CONDUIT-ENTERIC FISTULA, N=2 URINARY TRACT INFECTION, N-2 ILEUS AND N=1 PANPERITONITIS DUE TO RECTAL INJURY. IN CONCLUSION, THE SURGICAL TECHNIQUES OF THE PSS IN THE CREATION OF THE ICIC AND SHOWED THAT THESE TECHNIQUES FACILITATED THE CREATION OF THE ICIC. AS THE EXPERIENCE OF THE PSS INCREASED, THE SURGICAL TIME OF PROCEDURES INVOLVING THE PSS TENDED TO DECREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568910 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention