MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON CONTOUR W/ BLUE RELOAD; STAPLE, IMPLANTABLE

Catalog Number	GCS40B
Medical Device Problem Codes	Failure to Fire (2610); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a sigmoid colon procedure, when attempting to fire the stapler, the bottom row had visible holes and was leaking.The patient was fine and the leak was repaired.A new device was opened and worked properly.
Additional Manufacturer Narrative
(b)(4).Date sent 10/22/2025.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.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.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 there any other issue noted with the staple line other than leaking (malformed staples, staple line missing staples, etc.)? how was the leak addressed? 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 11/6/2025.D4 batch #849c24.Corrected data d4: udi#.Additional information was requested, and the following was obtained: 1.Was there any other issue noted with the staple line other than leaking (malformed staples, staple line missing staples, etc.)? surgeon said he thought and it looked like bottom row of staples had hole in it.2.How was the leak addressed? the reloaded the stapler with another green load and it worked.Unfortunately, they do not know which load was ¿bad¿ investigation summary the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample revealed that the gcs40b device was received with no apparent damage and with two reloads (b and c) present.The reloads were received void of staples, with the washer completely cut, drivers exposed and the knife recess below the cartridge deck.The device was tested for functionality with a test reload and the device fired, forming all staples and cutting as intended.The cut line and the staple line were completed and the staples meet the staple form release criteria.In addition, a reload and device tyveks were returned along with the device.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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 849c24, and no non-conformances were identified.

• Brand Name: ECHELON CONTOUR W/ BLUE RELOAD
• 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 ; 3035526892
• MDR Report Key: 23356822
• Report Number: 3005075853-2025-08176
• Device Sequence Number: 9091489
• Product Code: GDW
• UDI-Device Identifier: 10705036027515
• UDI-Public: (01)10705036027515(17)270131(10)849C24(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: GCS40B
• Device Lot Number: 849C24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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
• Patient Sex: Unknown