MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT; CLIP, IMPLANTABLE

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

Patient Problems Failure to Anastomose (1028); Unspecified Infection (1930); Pleural Effusion (2010)

Event Date 04/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 8/2/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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 number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via / events were submitted via 2210968-2022-06172, 2210968-2022-06173, 2210968-2022-06174.Citation cite: langenbeck's archives of surgery https://doi.Org/10.1007/s00423-022-02536-2.

Event Description

Title: simple and reliable transhiatal reconstruction after laparoscopic proximal gastrectomy with lower esophagectomy for siewert type ii tumors: y-shaped overlap esophagogastric tube reconstruction this study is aimed to evaluate the feasibility and safety of this novel method called the y-shaped overlap esophagogastric tube reconstruction, following laparoscopic transhiatal pgle by examining the short- and mid-term surgical outcomes including anastomosis-related complications.This retrospective study included the analysis of short- and mid-term surgical outcomes of 30 consecutive patients with siewert type ii esophagogastric junction adenocarcinoma who underwent laparoscopic pgle with y-shaped overlap esophagogastric tube reconstruction from april 2015 to august 2020.A novel method was used to form a 6-cm pseudofornix and an angle of his using the distal esophagus and a long gastric tube.The common entry hole was closed using a full-thickness intracorporeal running suture, 25 cm in length, using 3¿0 vicryl (ethicon gmbh, norderstedt, germany).Additional suturing in the seromuscular layer was completed using a running suture with 3¿0 pd, 20 cm in length, and lapra-ty clips (ethicon gmbh, norderstedt, germany) through the entry hole and both sides of the distal esophagus, to be fixed flatly on the anterior gastric tube.Soft silicone drain was placed around the anastomotic site through the seventh intercostal trocar under laparoscopic observation via the opened left diaphragm , which was closed by utilizing an intracorporeal suture using 2¿0 ethibond (ethicon).Reported complications included atelectasis/pleural effusion (n=7), anastomotic leakage (n=2), intraabdominal infection (n=1).This study demonstrated that the y-shaped overlap esophagogastric tube reconstruction of a pseudo-fornix and his angle with laparoscopic transhiatal approach was a safe and feasible approach.This technique should be considered as an alternative for laparoscopic transhiatal esophagogastric anastomosis for siewert type ii tumors with an esophageal invasion of = 4.0 cm.

Manufacturer Narrative

(b)(4).Date sent to the fda: 8/8/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15145399
• MDR Text Key: 297036829
• Report Number: 2210968-2022-06175
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention