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); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 07/07/2022

Event Type  Injury  

Event Description

Title: comparison of 5-year follow-up outcomes between primary and revision roux-en-y gastric bypasses after open vertical banded gastroplasty: an inverse propensity score-weighted analysis authors: mohamed hany1,2 · bart torensma3 · mohamed ibrahim1 · ahmed zidan1 · muhammad gaballah1 · ayman farouk mohammad ahmed aly1 · ghada ahmed abu-sheasha4 citation: obesity surgery (2022) 32:3023¿3033.Https://doi.Org/10.1007/s11695-022-06189-4 this retrospective study compared the 5-year follow-up outcomes of primary roux-en-y gastric bypass (prygb) and revision rygb (rrygb) after vertical banded gastroplasty (vbg).A total of 691 and 196 patients underwent prygb and rrygb procedures, respectively at the medical research institute, alexandria university, and madina women¿s hospital ifso-certified bariatric center from 2008 to 2016.Furthermore, 558 (116 were males; mean age 38.4 years) and 156 (42 were males) patients in the prygb and rrygb groups completed the 5-year follow-up, respectively.Surgery was performed using echelon flex endopath 60-mm linear stapler (ethicon endo-surgery, cincinnati, oh, usa), together with harmonic ace (ethicon endo-surgery, cincinnati, oh, usa) for dissection and vessel sealing before 2012, and shifted to the enseal (ethicon endo-surgery, cincinnati, oh, usa) later than 2012, non-absorbable sutures prolene (ethicon, somerville, new jersey) for closure of the mesenteric defects and enforcement of the staple line, vicryl (ethicon, somerville, new jersey) for closure of the gastrostomies and enterostomies after stapling, and used ethibond (ethicon, somerville, new jersey) for hiatal repairs before 2013.A competitor barbed suture was used at 2013.Reported complications include wound infection (n=3), melena (n=12), bleeding from port site (n=5) and bleeding from omentum (n=3) requiring laparoscopic exploration in the first 2 days after surgery, mesenteric vascular occlusion (n=7), leakage (n=2) which one case was successfully managed with percutaneous drainage alone while the other case had self expandable metallic stent (sems), protein malnutrition (n=5) which all required the laparoscopic reversal of the rygb by dismantling the gastrojejunostomy and performing a side-to-side gastro-gastric anastomosis between the pouch and remnant stomach, internal hernia (n=5) and port site hernia (n=5) which all required laparoscopic repair.In conclusion, rrygb in patients with vbg who regained weight showed comparable safety and resolution of associated diseases to that of prygb over the 5-year follow-up period.The weight loss in the rrygb group was acceptable despite being less than that of the prygb group.Ft was better after rrygb than that of prygb in the first year; however, both were comparable at the fifth year follow-up.Patients with vbg undergoing rygb should receive attentive treatment and evaluation of associated factors.

Manufacturer Narrative

(b)(4).Date of event: publication year of 2022.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 harmonic, enseal, and/or echelon flex devices 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15698591
• MDR Text Key: 302692805
• Report Number: 3005075853-2022-07380
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention