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

Catalog Number	GST60B
Medical Device Problem Codes	Structural Problem (2506); Difficult to Open or Close (2921); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/19/2026.D4: batch #598d28.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one gst60b reload (a) was received partially fired 1/5 and with an opened package.The returned reload was reset and loaded into a test device.The returned reload was tested for functionality with a test device in the straight position and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples met the staple form release criteria.The partially fired is consistent with an incomplete or interrupted cycle.As no device was returned for evaluation, we are unable to investigate further the issue of ¿difficult to open and would not reverse knife automatic".As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 598d28, and no non-conformances were identified.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 that during a lymphadenectomy with rectosigmoidectomy, while stapling the sigmoid, a gst60b exhibited premature firing.The surgeon was instructed to reverse the blade; after approximately three reversals the stapler could be opened.On the next cartridge the first fire occurred (flex stapler) and the instrument jammed again with the gst60b cartridge.We repeated the entire reversal process and the stapler opened.The cartridge was replaced with one from a different lot and the surgery proceeded.There was no patient consequence nor surgical delay reported.No additional information was provided.

• 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 00969 ; * 00969 ; 3035526892
• MDR Report Key: 25565917
• Report Number: 3005075853-2026-04770
• Device Sequence Number: 10012622
• Product Code: GDW
• UDI-Device Identifier: 10705036014706
• UDI-Public: (01)10705036014706(17)280531(10)620D23
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K183435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GST60B
• Device Lot Number: 620D23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Patient Sex: Unknown