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 Failure to Anastomose (1028); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2019; 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.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

Title: 'technique and prevention of postoperative complications after liver resections'.Authors: mustafin r.D; esin v.I; antonyan s.V; rudyk r.E; molchanova yu.R.Citation: medical news of north caucasus 2019; 14 (2):316 ¿ 319; doi: http://dx.Doi.Org/10.14300/mnnc.2019.14076.The purpose of the study at hand was to assess the effectiveness of different methods for dissecting the hepatic parenchyma during anatomical resections.From 2009 through 2015, 65 patients (male=44, female=21; mean age=65.5 years, age range=38-74 years) had undergone liver resections.In order to assess the effectiveness of the hepatic parenchyma transection methods used, the patients were divided into three groups: group one, within which the kelly technique was used to 29 patients; group two, within which the enseal bipolar coagulator-dissector (ethicon) was used in 20 patients; and group three which sonicision ultrasonic shears was used in 16 patients.Reported complications included bile leakage (n=?); bile flows (n=?) which required relaparotomies.In conclusion, the hepatic parenchyma dissection methods that was analyzed are effective and quite safe.However, the selection of a hepatic parenchyma dissection method during the performance of anatomical liver resections is a matter that is still under discussion and is largely dependent upon institutional technical support.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10757083
• MDR Text Key: 214322105
• Report Number: 3005075853-2020-05626
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention