MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 55 MM NTLC SELECTABLE RELOAD; 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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the unknown surgery, could not fire.Changed to another device to continue the surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/13/2026.D4 batch#: 181d67.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the reload was received with no apparent damage and along with its opened packaging.The reload had the proximal 2 drivers up and the remaining drivers down with staples present and a swing tab in the locked position.The reload swing tab was reset in order to fire the cartridge.During the functional testing, the reload cannot be fired.The reload was disassembled to verify the condition of the internal components and the wedge knife assembly was noted to be damaged no allowing fired the reload.No conclusion could be reached as to what caused the damage to the wedge knife assembly.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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: 181d67, and no non-conformance's were identified.

• Brand Name: 55 MM NTLC SELECTABLE 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: 24592706
• Report Number: 3005075853-2026-02011
• Device Sequence Number: 13128227
• Product Code: GDW
• UDI-Device Identifier: 10705036002826
• UDI-Public: (01)10705036002826(17)290831(10)267D92
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092577
• 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): 03/13/2026

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: SR55
• Device Lot Number: 267D92
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown