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 Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unknown.(b)(4).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.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 devices mentioned in this article caused/contributed to the reported events in the article? if information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported via journal article: title: comparison of short-term efficacy of metal stent combined with laparoscopy and emergency laparotomy in the treatment of colorectal cancer with acute intestinal obstruction.Authors: guo yang, luo chengyu.Citation: capital health development scientific research special funding project (initial 2017-4025-03); doi: 10.3877/cma.J.Issn.1674-3946.2020.04.015.The objective of this study was to compare the short-term efficacy of metal stent combined with laparoscopy and emergency laparotomy in the treatment of colorectal cancer with acute intestinal obstruction, and to seek a safe and effective treatment.The clinical data of 120 patients with colorectal cancer complicated with acute intestinal obstruction from january 2017 to march 2019 were retrospectively analyzed.The patients were divided into two groups according to surgical methods: 57 cases of metal stent combined with laparoscopy group and 63 cases of emergency laparotomy group.In the combined group intestinal stapler (johnson & johnson, usa) was utilized.Reported complications included colostomy (n=4) and received secondary closure, stoma (n=4) and stoma closure in the second stage was performed in only 2 patients, and infection.In conclusion metal stent combined with laparoscopy in the treatment of colorectal cancer with acute intestinal obstruction is safe, feasible, and has a good radical effect, which can effectively reduce the rate of two-stage operation.

Manufacturer Narrative

(b)(4).Date sent: 11/3/2021.Additional information was received: does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article? the author does not believe that.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12525937
• MDR Text Key: 273291089
• Report Number: 3005075853-2021-05713
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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
• Date Manufacturer Received: 10/26/2021
• Patient Sequence Number: 1