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

Catalog Number	SC60A
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Fire (2610); Difficult to Open or Close (2921); Mechanical Jam (2983); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a vats wedge resection, during the first firing to transect lung parenchyma, the knife stopped partway when the firing lever was squeezed and would not move forward.The red knife reverse lever could not be pushed down, and the jaws could not be opened, and the device completely could not be operated.A sales rep was present and attempted multiple times to operate the device.However, neither the closing lever nor the firing lever would move at all, and the red knife reverse lever could not be pushed down.Depressed, the arrow indicator on the side showed the ¿-¿ position (toward the handle side of the echelon).The firing count number (which normally displays 1, 2, 3 after firing) showed neither a number nor a lock symbol but instead appeared gray.Regardless of the several attempts, the knife could not be returned, and the jaws could not be opened.Due to the unavoidable situation, a new sc45a was opened at the doctor¿s decision and inserted beneath the non-functioning echelon.The non-functioning echelon and the transected tissue were removed together.After removal, it was necessary to open the jaws to retrieve the resected lung specimen.Direct manual attempts were made to open both the jaws and the lever, but neither could be opened despite the considerable force.As a result, the lung tissue site, which was not clamped by the echelon, was removed by scissors and the specimen was submitted.Fortunately, a margin had been secured.However, tissue remains clamped within the complaint device, sc60a.The cartridge color was gold.Another device was used to complete the case.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 6/19/2026 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: due to the unavoidable situation, a new sc45a was opened at the doctor¿s decision and inserted beneath the non-functioning echelon.The non-functioning echelon and the transected tissue were removed together.=> due to the unavoidable situation, a new sc45a was opened at the doctor¿s decision and inserted beneath the non-functioning echelon.The non-functioning echelon and the transected tissue were removed together.The used cartridges were gst45g×3 and gst45d×1, four firings in total.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: were there any patient consequences? if yes, what were they? did the post op care change in anyway due to the incident during the procedure? if yes, how? 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.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 ENDOPATH
• 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: 25562410
• Report Number: 3005075853-2026-04761
• Device Sequence Number: 18640922
• Product Code: GDW
• UDI-Device Identifier: 10705036002710
• UDI-Public: (01)10705036002710(17)271031(10)369D80
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081146
• 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,Followup
• Report Date (Section B): 06/30/2026

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: SC60A
• Device Lot Number: 369D80
• 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: 06/05/2026
• Supplement Date Received by Manufacturer: 06/22/2026; 06/29/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 06/24/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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: GST60D
• Patient Sex: Unknown