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

Catalog Number	PSEE45A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/17/2026 d4: batch #512d13.Additional information was requested, and the following was obtained: was the device locked on tissue with the jaws closed? -no.What troubleshooting steps were attempted to open the device (e.G.Squeezing the closing trigger while simultaneously depressing the anvil release button, knife reverse switch, manual override)? -press release button did the jaws eventually open? -yes.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 psee45a device was returned with no apparent damage and with a gst45w reload loaded on the device.The reload was received fully fired several b-formed staples on the deck and one side of edge was noted to be damaged.The damage to the reload is consistent with the device being clamped over a hard object.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 the device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples met the staple release criteria.The event described could not be confirmed as the device performed as intended and it opened and closed without any difficulties noted.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 512d13, 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 an unknown procedure, it was observed that after they installed the reload and closed the jaw, they could not open the jaw anymore.Another device was used to complete the procedure.There were no adverse consequences to the patient.No additional information could be provided.

• Brand Name: ECHELON FLEX
• 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: 25537228
• Report Number: 3005075853-2026-04688
• Device Sequence Number: 9358610
• Product Code: GDW
• UDI-Device Identifier: 10705036015352
• UDI-Public: (01)10705036015352(17)280229(10)A97N4W
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: PSEE45A
• Device Lot Number: A97N4W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GST45W
• Patient Sex: Unknown