MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS45 ENDO LINEAR CUTTER 45MM; STAPLE, IMPLANTABLE

Catalog Number	ETS45
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Wound Dehiscence (1154); Necrosis (1971); Insufficient Information (4580)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: de giacomo t, francioni f, venuta f, trentino p, moretti m, rendina ea, coloni gf.Complete mechanical cervical anastomosis using a narrow gastric tube after esophagectomy for cancer.Eur j cardiothorac surg.2004 nov;26(5):881-4.Doi: 10.1016/j.Ejcts.2004.07.024.Pmid: 15519175.The aim of this study was to trying to reduce the incidence of this complication, we describe our technique of cervical esophagogastric anastomosis using endoscopic linear stapler which seems to reduce the incidence of fibrous stricture formation after resection of esophageal cancer.Between march 2000 and june 2003, a total of 26 patients with resectable esophageal cancer underwent esophagectomy were included in the study.These patients includes 15 males and 11 females.With a mean age of 54.3 years, ranging from 43 to 72 years.These patients treated with endoscopic linear stapler (ets45 blue cartridge, ethicon endo-surgery) and are placed across the two opposite walls with the anvil on the esophageal lumen and the cartridge in the gastric tube.Follow-up of at least 3 months was recorded for every patient regarding symptoms and endoscopic features.Reported complications: endoscopic linear stapler (ets45 blue cartridge, ethicon endo-surgery).-anastomotic leak (n=1) treatment: complete spontaneous healing was achieved with cervical drainage and parenteral nutrition.-developed limited dehiscence of the abdominal wound (n=3) treatment: not reported.-respiratory complications treated successfully (n=2) -developed mediastinal recurrence (n=2) treatment: not reported.-due to gastric tube necrosis and subsequent mediastinitis (n=1) treatment: not reported.In conclusions, complete mechanical esophagogastric anastomosis, using endoscopic linear stapler is effective and safe, even when a narrow gastric tube is used as esophageal substitute.This technique seems superior to other techniques to reduce the incidence of post-operative anastomotic complications.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/21/2025.D4: batch # unk.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D4: udi: as the lot number for the device involved in the event was not provided, 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 obtained at a later date, 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? 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.

• Brand Name: ETS45 ENDO LINEAR CUTTER 45MM
• 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: 22862508
• Report Number: 3005075853-2025-06705
• Device Sequence Number: 20738813
• Product Code: GDW
• UDI-Device Identifier: 10705036000846
• UDI-Public: 10705036000846
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K020779
• 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): 08/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ETS45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/21/2025
• 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