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

Catalog Number	PLEE60A
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic thoracic procedure, the surgeon attempted to staple the lung tissue with the robotic stapler and it would not clamp.The surgeon then tried an echelon stapler with a black reload and it partially fired.The surgeon continued to try using the echelon staplers to complete the transaction, and ended up opening a total of 6 staplers and at least 15 reloads, but finally completed the transection.There were several staplers with bent anvils, indicating that the tissue was beyond limits for the stapler.No surgical delay or patient consequences were reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/14/2026 d4: batch #unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.Additional information was requested, and the following was obtained: the products were all discarded.Lot number information is not available.The surgeon cannot remember the sequence of events accurately.He stated that the thickness of the tissue was far too thick for stapling, but had no other options, so he kept trying, and breaking staplers.He finally debrided a pile of staples, cut through the calcified section, and completed the wedge with the stapler.There is no other information available.No lot or batch number was provided; therefore, a device history could not be done.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 FLEX
• 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: 50256596
• Report Number: 3005075853-2026-06684
• Device Sequence Number: 16014118
• Product Code: GDW
• UDI-Device Identifier: 10705036014614
• UDI-Public: 10705036014614
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: PLEE60A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Black Reload x15
• Patient Sex: Unknown