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

Catalog Number	GCS40B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2026.D4 batch #: 849c23.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis determined that the device was received with no apparent damage and with a gcr40g reload loaded.The reload was received with all staples present, the washer uncut, the knife recessed below the reload deck, and the drivers partially advanced.The drivers were manually returned to its home position and the device was tested for functionality with the returned reload and fired as intended, forming all staples and cutting as expected.The cut line and staple line were completed, and the staples met the staple form release criteria.The condition of the reload is consistent with the device being partially activated, resulting in the lockout being engaged when the device was reopened.Do not fire the instrument unless the closure trigger is properly latched against the handle.The firing trigger must be pulled back completely against the closure trigger to properly fire the instrument.If the firing sequence is not complete, staples may be deployed without cutting the washer and forming the staples.Please reference instructions for use for additional information.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 849c23, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during an unknown procedure the device would not fire.Surgical delay was unknown.No patient harm was reported.

• Brand Name: ECHELON CONTOUR W/ BLUE RELOAD
• 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 ; * ; 3035526892
• MDR Report Key: 23973748
• Report Number: 3005075853-2026-00134
• Device Sequence Number: 21488061
• Product Code: GDW
• UDI-Device Identifier: 10705036027515
• UDI-Public: (01)10705036027515(17)270131(10)C9DK65
• 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
• Report Date (Section B): 01/06/2026

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: GCS40B
• Device Lot Number: C9DK65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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