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

Catalog Number	PCEE45A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown thoracic procedure, after the staple line reinforcement was adhered to the jaws, there was a defect.The device became unusable.The cartridge color was gold.Another device was used to complete the case.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/6/2026 b3: unknown d4: batch #unk additional information was requested, and the following was obtained: during adhering the staple line reinforcement, the jaws did not open.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: - was the device locked on tissue with the jaws closed? if yes, how was the device removed? - 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)? if yes, how was the device removed from the patient? - did the jaws eventually open? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished #pcee45a, with lot/batch #a99h0x, 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/31/2026.D4: batch #828d55.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 pcee45a device was returned with no apparent damage and with a gst45d reload loaded on the device.The reload was received unfired.Additionally, an ech60r applicator and two buttress was on the reload deck and on the anvil were received.The device was tested for functionality in the straight position with a returned 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 828d55, and no non-conformances were identified.

• Brand Name: ECHELON FLEX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 25094048
• Report Number: 3005075853-2026-03428
• Device Sequence Number: 4968347
• Product Code: GDW
• UDI-Device Identifier: 10705036015338
• UDI-Public: (01)10705036015338(17)281231(10)A99H0X
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 05/06/2026

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: PCEE45A
• Device Lot Number: A99H0X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADDED IN ERROR.; GST45D.
• Patient Sex: Unknown