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

Catalog Number	GST45B
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ecchymosis (1818); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a gastric bypass the doctor said everything went well at first glance, when he is going to perform the postoperative control the same day in the afternoon he notices the patient with her hemodynamic parameters altered, they perform an endoscopy to check if there is any problem with the surgery and he realizes that close to the staple line of the gastric pouch and the gastrojejunal anastomosis that he performs manually, the patient has bruises and clots.Was there any harm to the reported patient or user? yes did the patient/user require any medical or surgical intervention as a result of the event? yes description: the patient had to undergo surgery again, since in the postoperative period the doctor performed an endoscopy and showed that the patient had bruises and clots in the gastrojejunal anastomosis, so it was decided to operate on her again.Did the patient/user require prolonged hospitalization as a result of the event? unknown what is the patient/user status after the event? now it's okay.Was there a significant delay?.
Additional Manufacturer Narrative
(b)(4).Date sent 6/8/2026 d4 batch # unk.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Additional information: dr.Performed a gastric bypass surgery where everything went well to the naked eye, when he is going to perform the postoperative control the same day in the afternoon note to the patient with his altered hemodynamics parameters, they perform an endoscopy to check if there is any problem with the surgery and it is noticed that close to the line of staples of the gastric pouch and the gastrojejunal anastomosis that he performs manually the patient presents hematomas and clots, therefore i require that you please check the batches of the refills used in this patient to see if there is any problem with them or if this batch has been reported previously and see if our refills may have failed.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: how was the post-op bleeding identified? - how many days postoperative was the bleeding identified? - what was the total estimated blood loss (ml)? - was a transfusion required? - how was the bleeding addressed? - what was the pre and postoperative anti-coagulant and pain management protocol? - was the bleeding intraluminal or extraluminal? - were the staples the appropriate b-shape form? - any clips, clamps, or graspers near the area where the device was being fired? - did the healthcare professional wait 15 seconds after closing the device before firing? - were there any issues with opening the device? if yes, what trouble shooting steps were used to open the device? - were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.- what color reloads were used and what was the sequence of the firings? - was a leak test performed? if so, what type and what was the result? - please provide a timeline of events.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: ECHELON ENDOPATH
• 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: 25428823
• Report Number: 3005075853-2026-04333
• Device Sequence Number: 10310464
• Product Code: GDW
• UDI-Device Identifier: 10705036014881
• UDI-Public: (01)10705036014881(17)280731(10)710D87
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K163454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: GST45B
• Device Lot Number: 710D87
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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: Female