MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	SR55
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the cartridge blade not coming out.Are there any reported cases of harm from patients or users? unknown.Was there a significant delay? unknown.
Additional Manufacturer Narrative
(b)(4) date sent 9/24/2026 d4 batch # 648d86.Investigation summary the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned reload.Visual analysis of the returned sample determined that one sr55 reload was received with no apparent damaged and the reload had the proximal 2 drivers up and the remaining drivers down with staples present and a swing tab in the locked position.However, when an attempt was made to fire the test device, the firing mechanism became jammed at the position where the drivers were deployed.As a result, no functional testing could be completed due to the condition of the reload.The reload was subsequently disassembled to assess the internal components.Examination revealed damage to one leg of the knife assembly, as well as damage to the reload body in the corresponding area.No conclusion could be reached how the knife assembly was damaged.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 648d86, and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.Could you please clarify if there were any patient consequences? it¿s unknown.2.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? it¿s unknown.

• Brand Name: N/A
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50883938
• Report Number: 3005075853-2026-07952
• Device Sequence Number: 10717956
• Product Code: GDW
• UDI-Device Identifier: 10705036002826
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K092577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial

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: SR55
• Device Lot Number: 671D65
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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 Sex: Unknown