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

Catalog Number	TLC75
Medical Device Problem Codes	Failure to Form Staple (2579); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 2/18/2026 b3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch # 747d80.Investigation summary the product was returned to ees for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the tlc75 device was received with no apparent damage and with a reload loaded in the device.The reload had the proximal 5 drivers up without staples, and the remaining drivers 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 and it fired, cut, and formed all the remaining staples as intended.The staple line and cut line were complete and the staples meet the staple form release criteria.The event reported of malformed staples was confirmed and it is related to improper use of the device.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 of difficult to open could not be confirmed as the device performed as intended and it opened and closed without any difficulties noted.As part of ees 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 747d80 , and no non-conformances related to the reported complaint condition were identified.Additional information was requested and the following was obtained: during dr.Case during the side-to-side anastomosis the surgeon fired the device without difficulty.When he pulled back the firing knob and began separating the handles, the device became stuck.At that point, he noticed that some of the staples had fallen and were not fully formed on the tissue.The team removed the reload, replaced it with a new one, and the subsequent firing functioned normally.I did confirm with the surgical tech that the device did cut, and the cut line was complete.The surgical tech and the surgeon informed the nurse coordinator, who then reached out to me regarding the issue.Fortunately, no patient harm occurred during this case.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 procedure, that the stapler failed.Stated that the stapler was not working.No further information provided.There were no patient consequences reported.

• 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: 24377614
• Report Number: 3005075853-2026-01383
• Device Sequence Number: 11980584
• Product Code: GDW
• UDI-Device Identifier: 10705036013211
• UDI-Public: (01)10705036013211(17)300831(10)747D80
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 747D80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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