MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE* LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number	TLC10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a colectomy the tlc100 was given to us from staff in or7.Reported as faulty.Subsequently told that it was opened for first firing and failed to fire; lockout there were no patient consequences.
Additional Manufacturer Narrative
(b)(4) date sent 6/16/2025 d4 batch #235d74 investigation summary the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample determined that the tlc10 device was received with no apparent damage and with a reload reload loaded in the device.The reload was received unfired, with some protruding staples along the staple line and 1 staple was noted to be missing at the midway staple line.In addition, body fluids were noted on the reload.The device was tested for functionality with a test reload and it fired, cut and formed all the staples as intended.The device fired without any difficulties, the staple line was complete, and the staples meet the staple form release criteria.It is possible that improper handling of the reload caused the staple to fell out, the proper handling instructions should be used when removing and reloading cartridges into the device, please reference the instructions for use.It should be noted that 100% inspection is performed by means of an automated vision system to ensure staples presence; the swing tab is present and unlocked.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.In addition, failure to complete the stroke may result in incomplete staple line.Please reference the instruction for use for more information.The event described could not be confirmed as the reload was received unfired and the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Although it could not be determine the cause of the reported incident, proper usage of the proximate linear cutter is important to ensure functionality.For more 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 235d74, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device tlc10 lot number m9a59r and no non-conformances were identified.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.

• 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: 22210811
• Report Number: 3005075853-2025-04529
• Device Sequence Number: 15519494
• Product Code: GDW
• UDI-Device Identifier: 10705036003120
• UDI-Public: (01)10705036003120(17)290930(10)M9A59R
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K020779
• 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): 06/16/2025

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: TLC10
• Device Lot Number: M9A59R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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