MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 55MM SELECTABLE NEW TLC; STAPLE, IMPLANTABLE

Catalog Number	NTLC55
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 1/12/2026.D4 batch#: 105d64.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 device was returned with a sr55 reload loaded on the device.In addition, an opened package was received along with the device.The reload was received with the knife not completely within the doghouse, and the proximal 6 drivers were up without staples while the remaining drivers were down with staples present.The returned reload had the swing tab in the locked position.The reload was reset and the device was tested for functionality with the returned reload; it fired, cut, and formed all the remaining staples as intended.The staple line and cut line were complete and the staples met the staple form release criteria.The event reported was confirmed and the condition of exposed knife is related to improper use of the device, specifically that the firing knob was not returned completely prior to opening the device, causing the knife not to return completely to its home position.The cartridge reload is designed to lockout as a safety feature if any staples have been fired from the cartridge reload.Failure to complete the stroke may result in an incomplete staple line.Please refer to the instructions for use for more information.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number: 105d64, and no non-conformance's 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 the unknown surgery, could not fire.Changed to the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: 55MM SELECTABLE NEW TLC
• 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: 24043454
• Report Number: 3005075853-2026-00378
• Device Sequence Number: 13026072
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)290430(10)129D14
• 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): 01/12/2026

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: NTLC55
• Device Lot Number: 129D14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SR55.
• Patient Sex: Unknown