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

Catalog Number	TCR75
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/5/2026.D4: batch # 382d39.Investigation summary: the product was returned to ethicon endo-surgery for thorough evaluation, which included visual inspections and functional testing of the returned reload.Visual analysis of the returned sample determined that the tcr75 reload was received with damage on the proximal reload deck and with the proximal 6 drivers up without staples and the remaining drivers down with staples present.In addition, 2 b-formed staples were noted on the damage of the deck and an opened packaging returned along with the reload.The returned reload had the swing tab in the locked position.No functional test was performed in order to preserve the evidence.The event reported was confirmed and it is related to improper use of the reload.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 an incomplete staple line.The damage to the reload is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the reload and interfering with the knife during device firing, prior to reloading the device, clean in sterile solution and then wipe the anvil and reload channel to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.Please reference the instruction for use for more information.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 382d39, 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.
Event or Problem Description
It was reported that during the unk surgery, could not fire.Changed another one to continue the surgery, the same problem happened again.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• 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: 24521357
• Report Number: 3005075853-2026-01831
• Device Sequence Number: 18555654
• Product Code: GDW
• UDI-Device Identifier: 10705036013136
• UDI-Public: (01)10705036013136(17)290831(10)286D48
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/05/2026

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: TCR75
• Device Lot Number: 286D48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown