MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDO ILS 21MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number	ECS21A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 9/18/2025.D4 batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: could you please clarify if there were any patient consequences? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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.
Event or Problem Description
It was reported that during a lap gastrectomy surgery, after fired, noted the cut line was ok, but without any staples.Changed the new one to complete surgery.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/13/2025.Additional information was requested, and the following was obtained: 1.Could you please clarify if there were any patient consequences? -no.2.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? -no.
Additional Manufacturer Narrative
(b)(4).Date sent 11/10/2025.Corrected data d4: udi# a manufacturing record evaluation was performed for the finished device lot/batch number c9ek93 and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/8/2025.D4: batch # 169d35.Investigation summary: the product was returned to ethicon endo-surgery for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample revealed that the ecs21a device arrived with no apparent damage.The breakaway washer was present, cut and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.In addition, the device was visually inspected and the checkpoint of vision system for presence of staples was present.The event described could not be confirmed as the device was returned without detectable damage.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 169d35, and no non-conformances were identified.

• Brand Name: ENDO ILS 21MM, CURVED
• 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: 23083055
• Report Number: 3005075853-2025-07401
• Device Sequence Number: 20020767
• Product Code: GDW
• UDI-Device Identifier: 10705036003489
• UDI-Public: (01)10705036003489(17)290630(10)C9EK93(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K940967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2025

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: ECS21A
• Device Lot Number: C9EK93
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 10/23/2025; 11/13/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/10/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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