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

Catalog Number	GCS40G
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a low anterior resection procedure, when opened, the item was broken.It was not used and a replacement item was opened.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/14/2026.D4: batch#: 715d76.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the gcs40g device was received inside the opened packaging with no apparent damage and with a reload loaded in the device without stapler retainer.The reload was received fully loaded with staples, with the washer uncut, with the drivers and with the knife recess below the reload deck.The reload was not properly loaded in the device, as the retaining pin was not connected to the coupler and pushrod.In addition, the washer had some blood stains.These facts indicate that the reload was removed and reinserted incorrectly and/or incompletely after the retainer was removed.The returned reload was pulled out of the device and placed back on; the device opened and closed without any difficulties.The device was tested for functionality with an returned 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, slightly marks were noted in the lockout shelf.It should be noted that if the reload is removed from the device, whether the reload is spent or not, and if the staple retainer has already been removed from the reload, the reload cannot be reloaded into the device.Regarding to lockout shelf indented, is possible that an attempt was made to close the device with a reload not properly loaded or with a spend reload, this condition would lock the device giving the impression that the device will not close.The echelon contour¿ curved cutter is designed with a feature that prevents closure if a used reload, no reload, or an incorrectly inserted reload is in the instrument.The used or misloaded reload module should then be replaced with a new reload or, if no reload was present, a reload should be loaded in the instrument.After following the above steps, any device which does not close either partially or completely should not be used.Please reference the instructions for use for the complete guide loading and reloading the instrument.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Device history review: a manufacturing record evaluation was performed for the finished device batch number: 715d76, and no non-conformance's 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.

• Brand Name: ECHELON
• 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: 24873630
• Report Number: 3005075853-2026-02819
• Device Sequence Number: 15973563
• Product Code: GDW
• UDI-Device Identifier: 10705036027508
• UDI-Public: (01)10705036027508(17)280731(10)A98P1T
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: GCS40G
• Device Lot Number: A98P1T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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 Age: 61 YR
• Patient Sex: Unknown