MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH XL SEAL 25MM; STAPLE, IMPLANTABLE

Catalog Number	ECS25B
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 3/3/2025.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.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 device caused or contributed to the patient complications mentioned 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
It was reported via journal article: title: new purse-string suture clamp and multi-functional seal cap: a simple intracorporeal circular-stapled oesophagojejunostomy after laparoscopic total gastrectomy authors: jianjun du, junjie liu, lizhi zhao, haohai jiang, ziqiang zhang, citation: langenbeck's archives of surgery (2025) 410:9.Https://doi.Org/10.1007/s00423-024-03571-x.The aim of this study was to evaluate and analyze the surgical details and postoperative outcomes of this "lap-psc with msc technique".Between may 2023 and october 2023, a new laparoscopic purse-string suture clamp (lap-psc) and multi-functional seal cap (msc) were applied to obtain a simple intracorporeal circular-stapled oesophagojejunostomy after laparoscopic total gastrectomy in 21 patients (16 male and 5 females; mean age of 63.6±9.2 years) with gastric cancer in the authors' hospital.A 25-mm anvil tied with a 2-0 thread (braided nylon, surgilon; medtronic, minneapolis, mn) on the tip of the anvil central rod (ethicon¿ circular stapler; ecs25b; ethicon endo-surgery, cincinnati, oh) was placed into the abdominal cavity through a separate 3-cm incision on the left middle clavicular line above the level of the umbilicus (fig.3f).Reported complications include wound infection (n=1) and abdominal infection (n=1).In conclusion, the standardized single-stapling end-to-side oesophagojejunostomy in open surgery can be easily and safely performed during ltg using both lap-psc and msc.The procedure using lap-psc with msc may be considered as a better procedure to option in ltg.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/5/20258.Additional information was requested, and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? no.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.

• Brand Name: CIRCULAR MECH XL SEAL 25MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21504212
• Report Number: 3005075853-2025-01643
• Device Sequence Number: 20826676
• Product Code: GDW
• UDI-Device Identifier: 10705036022923
• UDI-Public: 10705036022923
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: ECS25B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown