MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 5MM ROUND TIP 35CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSEAL535RE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Abnormal Vaginal Discharge (2123)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: efficacy and safety of electrothermal bipolar vessel sealer vs enseal in total laparoscopic hysterectomy for large uterus: a comparative study in mysuru, south india authors: prathap talwar, swathi hassan kumarachar, lakshmi velayudam, tohreen fathima, citation: world journal of laparoscopic surgery (2021); 14(1):5-9.Doi: 10.5005/jp-journals-10033-1431.The aim of this prospective randomized case-control study was to compare the efficacy, safety, and perioperative outcomes of alan vessel sealer vs enseal in laparoscopic hysterectomy for a large uterus of more than 12-week size.A total of 100 women with fibroid uteri of size between 12 weeks and 28 weeks were included in the study.Of them, 50 women (mean age 43.68 ± 5.35 years; mean bmi of 25.37 ± 2.47) underwent total laparoscopic hysterectomy (tlh) using a competitor device (group a), and the remaining 50 women (mean age of 45.06 ± 5.79 years; mean bmi of 25.52 ± 2.25) (group b) underwent tlh using enseal device (nseal535re, ethicon endo-surgery).Reported complications include secondary hemorrhage (n=1) which were managed conservatively by vaginal packing and tranexamic acid, leukorrhea/ vault granulation (n=3) which were treated conservatively with a course of oral and local antibiotics, and vesicovaginal fistula (n=1) which were further managed by a urologist.In conclusion, laparoscopic hysterectomy is a safer alternative to open hysterectomy even in a large uterus.The alan vessel sealer is comparably safe and as efficient as enseal.It is more cost-effective with its reusable hand instruments; hence, could be a promising instrument for patients undergoing laparoscopic hysterectomy in developing countries like india.

• Brand Name: ENSEAL 5MM ROUND TIP 35CM
• 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12700254
• MDR Text Key: 278533947
• Report Number: 3005075853-2021-06413
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSEAL535RE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention