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

Catalog Number	TLC10
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a gastrectomy procedure there was a broken handle.
Additional Manufacturer Narrative
(b)(4).Date sent 3/13/2025 d4 batch #101c80 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 revealed that the tlc10 device was received with the anvil shroud broken and the pin latch was missing and not returned for analysis with no reload present.Due to the condition of the device not functional test was performed.The event reported was confirmed and it is related to improper use of the device.It is possible that the damage was due to improper handling of the device.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 101c80, and no non-conformances related to the reported complaint condition were identified.A manufacturing record evaluation was performed for the finished tlc10, with lot/batch number x9616x, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what part of the device was broken (firing knob, anvil, locking lever)? did any pieces fall into the patient? if yes, were they retrieved? will all pieces be returned with the device? if no, were they discarded? is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event?.

• 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: 21596971
• Report Number: 3005075853-2025-01976
• Device Sequence Number: 18377425
• Product Code: GDW
• UDI-Device Identifier: 10705036003120
• UDI-Public: (01)10705036003120(17)270930(10)X9616X
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: X9616X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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