MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ECHELON ENDOPATH; STAPLE, IMPLANTABLE

Catalog Number	GST45B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the gst reload couldn't fire properly.Was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no incidence of infection or inflammation, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.
Additional Manufacturer Narrative
(b)(4).Date sent 8/31/2026.D4 batch # 812d43.Investigation summary.The product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that one gst45b reload was received fully fired.Upon further inspection, the reload was found to have damaged on the knife channel, it is possible that the knife may push the staple line and tissue forward shaving the reload knife channel.No functional test could be performed due to the condition of the reload.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.Please reference the instruction for use for more information.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 812d43, and no non-conformances were identified.Additional information was requested, and the following was obtained: please explain in detail what was the issue with the device.Was the firing sequence started but not completed? yes if yes: did the device deliver any staples? na.If yes, were the staples formed properly? na.If yes, was the staple line complete? na.Did the device cut? no.If yes, was the cut line complete? na.If yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? na.Was there any difficulty opening the device? no.If yes, how was the device removed from the patient? na.If yes, did the jaws eventually open? na.

• 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 ; PR ; +1(303)552-6892
• MDR Report Key: 50526539
• Report Number: 3005075853-2026-07267
• Device Sequence Number: 20343670
• Product Code: GDW
• UDI-Device Identifier: 10705036014881
• UDI-Public: (01)10705036014881(17)281130(10)846D08
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K163454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: GST45B
• Device Lot Number: 846D08
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2025
• 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