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

Catalog Number NSEALXXX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 04/27/2020.Date of event: unknown.Batch # unknown.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.

Event Description

It was reported via journal article: title: the immediate results of applying various ways of forming ileotransverse anastomosis in right hemicolectomy in oncology practice authors: glushkov e.A., nikitin n.A., ivanov a.D., kislichko s.A.Citation: vyatka medical herald, no.3 (63), 2019: 22-26.Doi: 10.24411/2220-7880-2019-10005.The objective of this study was to introduce the invagination ileotransverse anastomosis (ita) proposed by nikitin into the practice of performing right-sided hemicolectomy in planned oncology and to study the immediate results of its use as compared to an end-to-side transverse ita and a longitudinal lateral ita.The study included 73 patients (age range:43 to 83 years) with confirmed adenocarcinoma of the right half of the colon in stages i-iv, who underwent treatment over the period extending from 2017 through 2018 and who were represented by three groups as a function of the ita formation method used: nikitin's ita group included 22 observations (10 male and 12 female; age: 67±8.6 years; bmi: 23.2±4.4 kg/cm2); trans-verse end-to-side ita group included 21 observations (13 male and 8 female; age: 64±7.6 years; bmi: 26.7±4.8 kg/cm2); and longitudinal lateral ita group included 30 observations (17 male and 13 female; age: 65±9.4 years; bmi: 25.9±5.1 kg/cm2).During the procedure, the surgical release of the right half of the colon and lymphodissection were carried out using the enseal technology (enseal, bipolar; ethicon).An ntlc 75 linear cutter (ethicon) was used during intestine transection.Reported complication in the nikitin's ita group included in the pain syndrome (n-?).Reported complication in the trans-verse end-to-side ita group included in the pain syndrome (n-?).Reported complications in the longitudinal lateral ita group included in the pain syndrome (n-?) and bleeding (n-1) in which the patient required a second surgical intervention.The best results were obtained in patients with invaginational ita according to nikitin, the worst in patients with longitudinal ita side to side.

• 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: 10001118
• MDR Text Key: 194671301
• Report Number: 3005075853-2020-02351
• 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: Physician
• Type of Report: Initial
• Report Date: 03/30/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention