MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. Echelon Endopath; STAPLE, IMPLANTABLE

Catalog Number	GST60B
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
T was reported that during an unknown procedure, it was observed that some staples fell off when they opened the packaging.Changed to a new one to complete the procedure.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/10/2026 d4: batch #985d34 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 revealed that the gst60b reload was received with no apparent damage.The sled was received in the home position; however, four double drivers and 2 single drivers were noted up without staples on the proximal end, this condition was most likely due to the sled movement.The condition of the driver's up shows that reload was partially fired 1/4 causing the reported event.However it is possible that the reload was manipulated, and the sled was manually returned to its home position.The returned reload was reset and loaded into a test device.It 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 condition is consistent with an incomplete or interrupted cycle.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number of 109e93 / 22gst60b , and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 985d34, 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.

• Brand Name: Echelon Endopath
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; PR 00969 ; +1(303)552-6892
• MDR Report Key: 50195238
• Report Number: 3005075853-2026-06451
• Device Sequence Number: 18620707
• Product Code: GDW
• UDI-Device Identifier: 10705036014706
• UDI-Public: (01)10705036014706(17)290430(10)109E93
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K183435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 109E93
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2026
• 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