MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL GENERIC PRODUCT CODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSEALXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 09/17/2021

Event Type  Injury  

Event Description

Title: laparoscopic sleeve gastrectomy versus laparoscopic greater curvature plication: a long-term follow-up study on the complications, body mass index changes, endoscopic findings and causes of revision.Authors: mohamed ibrahim, mohamed hany, ahmed zidan, anwar ashraf abouelnasr, ghada ahmed abu-sheasha.Citation: obesity surgery (2021) 31:5275¿5285, https://doi.Org/10.1007/s11695-021-05683-5.The aim of this study was to compare the long-term outcomes and clinical relevance of laparoscopic sleeve gastrectomy (lsg) and laparoscopic greater curvature plication (lgcp) in a matched controlled single bariatric centre study.Between january 2015 and february 2016, 163 patients who underwent either laparoscopic sleeve gastrectomy or laparoscopic greater curvature plication for morbid obesity were included in the study.A total of 79 patients (60 females, 19 males, mean age 35.7 ± 8.3 years, mean bmi 44.3 ± 2.3 kg/m2) underwent laparoscopic greater curvature plication while 84 patients (67 females, 17 males, mean age 35.0 ± 9.1 years, mean bmi 43.1 ± 2.8 kg/m2) underwent laparoscopic sleeve gastrectomy.For the laparoscopic greater curvature plication procedure, the enseal (ethicon endo-surgery) was used to divide the gastrocolic omentum 3¿5 cm proximal to the pylorus which continued up to the angle of his.The fundus was completely dissected then the gastric plication was performed using the 2/0 ethibond suture (ethicon).For the laparoscopic sleeve gastrectomy procedure, all procedures were performed using a technique similar to that used for the laparoscopic greater curvature plication procedure.An echelon flex endopath 60-mm direct stapler (ethicon endo-surgery) was used for gastric division, beginning at 3¿5 cm before the pylorus and up to the angle of his.The entire staple line was invaginated using continuous seromuscular sutures with 3/0 pds sutures (ethicon).The reported complications included gastric leakage (n=1), bleeding of the short gastric vessels (n=1), nausea (n=11), vomiting (n=11), epigastric pain (n=24), gastroesophageal reflux (n=?), bile reflux (n=?), and weight gain (n=?).In conclusion, laparoscopic greater curvature plication has a higher rate of complications, a much less durable effect on weight loss, a higher rate of revision surgery and a higher cost burden to the health care system than laparoscopic sleeve gastrectomy.

Manufacturer Narrative

(b)(4).Event date: publication year of 2021.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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ENSEAL GENERIC PRODUCT CODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15470757
• MDR Text Key: 300443731
• Report Number: 3005075853-2022-06337
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention