MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN); LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # unknown.The lot/ batch was not provided; therefore, the manufacturing records evaluation could not be performed.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.What is the specific number of patients in the hand-sewn group who experienced abdominal infection?.

Event Description

It was reported via journal article: title: comparison of outcomes following end-to-end hand-sewn and mechanical oesophagogastric anastomosis after oesophagectomy for carcinoma: a prospective randomized controlled trial, authors: quan-xing liu, yuan qiu, xu-feng deng, jia-xin min and ji-gang dai; citation: european journal of cardio-thoracic surgery 47 (2015) e118¿e123, doi:10.1093/ejcts/ezu457.The present study was designed to clarify the controversy of using the hand-sewn method and circular stapler method in oesophagogastric anastomosis after oesophagectomy and gastric tube reconstruction.This prospective randomized controlled trial involves 478 patients treated for oesophageal tumour between february 2009 and december 2011.The patients were randomized to have the end-to-end oesophagogastric anastomosis constructed by hand or by stapler after a lewis¿tanner oesophagectomy; hand-sewn group included 237 patients (176 male and 61 female; mean age: 61±9 years) and 241 patients (183 male and 58 female; mean age: 62±8 years) in the stapler group.During the procedure, the tubular stomach was created by means of a 75-mm linear cutter stapler (proximate linear cuttertlc75; ethicon).In the hand-sewn group the oesophagogastric anastomosis was performed with a single layer of interrupted absorbable monofilament sutures.Ils circular staplers (proximate ils stapler; ethicon) were used in the stapled anastomosis group.The stapling device was introduced through a gastrotomy created in the region where the lesser curvature was resected.The gastrectomy was closed using the aforementioned liner stapler technique.The same technique of the stapler was used for both thoracic and transhiatal resections.Transhiatal oesophagogastrectomy (tho) with cervical oesophagogastric anastomoses was performed in 54 patients of the handsewn group and 59 patients of the stapled group.Reported complication in hand-sewn group included abdominal infections (n-?) reported complication in stapler group included radiological and clinical anastomotic leakage (n-7) in which all these patients were managed with intravenous nutrition and chest tube drainage and all patients healed on conservative management, anastomotic stricture (n-31) which were easily and safely treated by endoscopic dilatations, and abdominal or thoracic infections (n-8).It is obvious that the anastomotic technique (whether hand-sewn or stapled) had the most significant bearing on stricture, and the reasons why stricture was more common with the stapler method may be as follows.First, the lack of accurate mucosa-to-mucosa apposition (with the edges separated by two thicknesses of bowel wall) may play an important role in causing the raw surface to heal by second intention with granulation tissue formation.Secondly, tissue necrosis beyond the staple line, inflammation and delayed epithelialization may also predispose to excessive fibrosis and stricture formation.Thirdly, the unabsorbed, circumferentially placed metal staples do not allow the lumen to dilate beyond the size obtained originally.In conclusion, the stapler method could be used as a superior method for oesophagogastric anastomosis after oesophagectomy for oesophageal carcinoma.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 9967312
• MDR Text Key: 194696596
• Report Number: 3005075853-2020-02192
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention