MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; LAPROSCOPE, GENERAL & PLASTIC SURGERY

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

Patient Problems Failure to Anastomose (1028); Abscess (1690); Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422); Blood Loss (2597); Not Applicable (3189); No Code Available (3191)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(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 number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the author/surgeon believe that ethicon products (prolene suture and endoloop suture) involved caused and/or contributed to the post-operative complications described in the article? does the author/surgeon believe there was any deficiency with the ethicon products (prolene suture and endoloop suture) used in this procedure? were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Please provide patient demographics.Citation: j gastric cancer.2019; 19(2): 193-201.Doi: https://doi.Org/10.5230/jgc.2019.19.E17.

Event Description

Title: intracorporeal esophagojejunostomy using a circular or a linear stapler in totally laparoscopic total gastrectomy: a propensity-matched analysis there is no consensus on the optimal method for intracorporeal esophagojejunostomy (ej) in laparoscopic total gastrectomy (ltg).This study aims to compare 2 established methods of ej anastomosis in ltg.A total of 314 patients diagnosed with gastric cancer that underwent ltg in the period from january 2013 to october 2016 were enrolled in the study.254 patients underwent the procedure with circular stapler (174 male and 80 female patients; age: 61.5 ± 11.9; bmi: 23.3 ± 3.1) and 60 patients underwent with linear stapler (49 male and 11 female patients; age: 61.9 ± 12.7; bmi: 23.6 ± 2.9).For the circular stapler anastomosis, reinforcement of the purse-string suture is performed using an additional prolene 2-0 suture (ethicon) or the endoloop (ethicon).For the circular stapler anastomosis group, reported complications included intracorporeal esophagojejunostomy (ej) leakage (n-3), anastomosis leakage (n-7) which required reoperation, bleeding from the ej site (n-1), ej stricture (n-1), intra-abdominal abscess (n-13), stump leakage (n-2), loop obstruction (n-1), internal hernia (n-10), adhesive ileus (n-7), other late complications (n-2).Performing the ej anastomosis is still considered one of the most technically challenging aspects of ltg.Both circular and linear stapling techniques are feasible and safe in performing intracorporeal ej anastomosis during ltg.The linear group had shorter operative time, but there was no difference in anastomosis complications.

Manufacturer Narrative

Date sent to the fda: 11/16/2020 corrected information: b1, b2, h1- upon additional information review, this medwatch report 2210968-2020-08472 does not meet reportability criteria and has been updated from serious injury to not-reportable.Additional information was requested from the surgeon/author, and the following was obtained: does the author/surgeon believe that ethicon products (prolene suture and endoloop suture) involved caused and/or contributed to the post-operative complications described in the article? - no.We do not think it was caused by the products mentioned above.Does the author/surgeon believe there was any deficiency with the ethicon products (prolene suture and endoloop suture) used in this procedure? - no.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: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10760344
• MDR Text Key: 214743812
• Report Number: 2210968-2020-08472
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention