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

Catalog Number	NTLC55
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 8/4/2025.D4 batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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 an unknown surgery, after fired, the firing knob fell off.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4), date sent 9/29/2025, d4 batch #326d35.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 ntlc55 device was received with the firing mechanism damaged as the firing knob was detached and the slip block assembly was noted to be broken.And returned inside of a plastic bag and with a sr55 reload no loaded in the device.The reload had the proximal 4 drivers up and the remaining drivers down with staples present and the swing tab in the locked position.No functional test could be performed due to the condition of the device.The event reported was confirmed and it is related to improper use of the device.The damage to the firing knob is consistent with high (outside indicated use) staple forming forces; however, there is insufficient evidence to determine the cause of the higher loads.It should be noted that the cartridge reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.If enough force is applied the device could be damaged.For additional information please refer to the instructions for use.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 326d35, and no non-conformances were identified.

• Brand Name: 55MM SELECTABLE NEW TLC
• 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: 22704309
• Report Number: 3005075853-2025-06153
• Device Sequence Number: 9035772
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)291031(10)344D13
• 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,Followup
• Report Date (Section B): 09/29/2025

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: NTLC55
• Device Lot Number: 344D13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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