MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number XCEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hernia (2240); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event: this is a journal article.The publication year is 2020.This report is related to a journal article; therefore, no product will be returned for analysis.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.Please confirm what are the specific ¿surgical failure¿ and ¿major complications¿ mentioned in table 3 of the article? to date, no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during review of journal article, title: comparison of surgical outcomes between integrated robotic and conventional laparoscopic surgery for distal gastrectomy: a propensity score matching analysis authors: chul kyu roh, seohee choi, won jun seo, minah cho, yoon young choi, taeil son, woo jin hyung, hyoung-il kim citation: scientific reports.2020; 10: 485.Doi: https://doi.Org/10.1038/s41598-020-57413-z.This study was aimed to compare the surgical outcomes between conventional laparoscopic distal gastrectomy (cldg) and integrated robotic distal gastrectomy (irdg) which used both single-site platform and fluorescence image-guided surgery technique simultaneously.Retrospective data of 56 patients (age: 56.4 ± 11.5 years; 28 male and 28 female patients; bmi: 23.9 ± 2.9) who underwent irdg and 152 patients (age: 61.8 ± 10.7 years; 90 male and 62 female patients; bmi: 24.1 ± 3.5) who underwent cldg were analyzed.During the irdg procedure, reduced-port robotic gastrectomy using single-site platform for si system has been described previously 13.In this paper, surgical procedures are described for xi systems.It illustrates schematic assignment of robot arms for single-site.An excel 12-mm port (ethicon) was inserted along the right flank, and an 8-mm straight cannula was inserted in a port-in-port manner docked on the first robotic arm for equipping harmonic ace ultrasonic curved shears (ethicon).Single-site port positioned at umbilical site had four lumens for instruments.A closed suction drain was inserted through a 12-mm port site in the right flank.After drain placement, the umbilical wound for single-site was closed in layers as follows.First, the peritoneum and fascia layer were closed interruptedly with vicryl plus 1-0 sutures (ethicon).Next, for the umbilical wound, subcuticular sutures of both sides of the skin were performed using vicryl plus 4-0 sutures (ethicon).In the irdg group, reported complications included internal herniation (n-1), surgical failure (n-1) in which the patient was readmitted due to complication identified in outpatient clinic, and major complication (n-1).It was reported that the surgical outcomes following irdg were notable to those of cldg in terms of retrieved lns, estimated blood loss, and readmission, but unfavorable in operation time.In conclusion, irdg using the single-site platform and fluorescence image-guided lymphadenectomy appears to provide potential benefits in surgical outcomes compared to cldg for patients with early gastric cancer.

• Brand Name: ENDOPATH XCEL TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10299048
• MDR Text Key: 200830413
• Report Number: 3005075853-2020-03684
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XCEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention