MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*75MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number	TLC75
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, the instrument was locked during firing and second one had the same problem.There was no delay in the procedure and the procedure was completed successfully.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/20/2026.D4: batch # 504d37.Investigation summary: the product was returned to ethicon endo-surgery for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample determined that the tlc75 device was received with no apparent damage and with a tcr75 reload present.The reload had the proximal 22 drivers up without staples, and the remaining drivers down with staples present and the swing tab in the locked position.The reload was reset and the device was tested for functionality with the returned reload and it fired, cut, and formed all the remaining staples as intended.However, 1 protruding staple and one missing on the distal end were observed, this staple does not created a fluid path.The reported events were confirmed and are related to improper use or handling of the device and reload.It is possible that improper handling of the reload caused staples to fall out, and failure to complete the stroke may result in an incomplete staple line.The reload is designed to lock out as a safety feature if any staples have been fired.Proper handling instructions should be used when removing and reloading cartridges, and users should reference the instructions for use for more information.100% inspection is performed by means of an automated vision system to ensure staples presence.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Device history review: a manufacturing record evaluation was performed for the finished device batch number 504d37, 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: 24401060
• Report Number: 3005075853-2026-01475
• Device Sequence Number: 13194281
• Product Code: GDW
• UDI-Device Identifier: 10705036013211
• UDI-Public: (01)10705036013211(17)300228(10)533D45
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 02/20/2026

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: TLC75
• Device Lot Number: 533D45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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