MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 60 ENDOPATH STAPLER; STAPLE, IMPLANTABLE

Catalog Number	EC60
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 7/18/2025 d4: batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.Attempt made to obtain the following information.To date, a response has not been received.Should additional information be received, a supplemental report will be submitted.Does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article? if yes, please explain.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
Event or Problem Description
Title: comparison of short-term efficacy of minimally invasive versus open esophagogastric junction adenocarcinoma authors: ren tingkai, yang xuefeng, dong yanjun, zheng xianjie, zhang shuanglin citation: journal of henan university (medical science) doi: doi: 10.15991/j.Cnki.41- 1361/r.2020.03.009.The aim of this study is to compare the effect of minimally invasive modified ivor-lewis operation and left thoracotomy on adenocarcinoma of esophagogastric junction.Between june 2016 to july 2018, a total of f 56 patients with aeg who underwent surgery in the first affiliated hospital of henan university.There were 33 males and 23 females; the age of the whole group was 53 years; there were 12 cases of siewert type i, 38 cases of type ii, and 6 cases of type iii.In control group : in the right lateral decubitus position, the chest was entered through a posterolateral incision in the left 6th or 7th intercostal space, unilateral lung breathing was performed, the esophagus and aorta were freed, the upper mediastinal, paraesophageal, and subcarinal lymph nodes were dissected, the diaphragm was opened, and the esophagus and gastric tissues were cut 5 cm from the upper and lower edges of the tumor with a linear cutter stapler ec60 blue nail to create a tubular stomach and gastroesophageal end-to-side anastomosis was performed with a johnson & johnson stapler (cs25).Harmonic scalpel to divide the short gastric artery and free the greater curvature of stomach; open the hepatogastric ligament, free the left gastric artery, use the johnson & johnson biological clip to clamp and transect the left gastric vessel.Reported complications are: -anastomotic leakage (n=1).In conclusion, the modified ivor-lew- is operation is superior to left thoracotomy in the treatment of esophagogastric junction adenocarcinoma.It can shorten the hospital stay, and the lymph node dissection is more thorough.The curative effect is satisfactory.It has higher clinical value.

• Brand Name: ECHELON 60 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 22544179
• Report Number: 3005075853-2025-05692
• Device Sequence Number: 15258411
• Product Code: GDW
• UDI-Device Identifier: 10705036001690
• UDI-Public: 10705036001690
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: EC60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown