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

Catalog Number	TCR10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 2/3/2025.D4 batch #u5c67y.Investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that the tcr10 reload was received with both reload forks broken off making the reload nonfunctional.The reload had the proximal 15 drivers up and the swing tab in the locked position.No functional test was performed due to the condition of the reload.The event reported was confirmed and it is related to improper use of the device.The forks on the reload have consisted of an improper loading technique.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.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 u5c67y, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device tcr10 lot number u4089l 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: 1.Could you please clarify if there were any patient consequences? 2.Could you please clarify if there was any change in the post-operative care of the patient as a result of the event?.
Event or Problem Description
It was reported that during a gastrectomy the reload did not fire.

• 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: 21292415
• Report Number: 3005075853-2025-00875
• Device Sequence Number: 7585905
• Product Code: GDW
• UDI-Device Identifier: 10705036003045
• UDI-Public: (01)10705036003045(17)250331(10)U4089L
• 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): 02/03/2025

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 Expiration Date: 03/31/2025
• Device Catalogue Number: TCR10
• Device Lot Number: U4089L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2020
• 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