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	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the firing not possible due to trigger malfunction.
Additional Manufacturer Narrative
(b)(4) date sent 2/18/2025 d4 batch #640c60.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 tlc10 device was received with no apparent damage with a reload no loaded.The reload was received fully fired with the swing tab in the locked position and with the gripping surface from the right side broken off.In addition, a right fork piece was found lodged in the channel area of the device and it does not belong to the returned reload.The device was tested for functionality with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete, and the staples meet the staple form release criteria.The event reported was confirmed and it is related to improper use of the device.The condition of the gripping surface and fork broken is consistent with an improper loading technique.When loading the cartridge in the device, make sure the cartridge is inside the channel track and the proper loading technique 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.A manufacturing record evaluation was performed for the finished device batch number 640c60, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device tlc10 lot number c9dc09 and no non-conformances were identified.Manufacturing date: 01/25/2024 expiration date: 12/31/2028 additional information was requested, and the following was obtained: 1.Could you please clarify if there were any patient consequences? since it was not used on the patient, there was no impact on the patient.2.Could you please clarify if there was any change in the post-operative care of the patient as a result of the event? since it was not used on the patient, there was no change in the post-op care.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21404995
• Report Number: 3005075853-2025-01271
• Device Sequence Number: 8523696
• Product Code: GDW
• UDI-Device Identifier: 10705036003120
• UDI-Public: (01)10705036003120(17)280930(10)C9DC09(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/18/2025

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: C9DC09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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