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

Catalog Number	TCR10
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 12/18/2025 b3: exact event date unk, entered 1/1/2025 as only the year was provided.D4: batch # unk.Investigation summary the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the tcr10 cartridge was received with no apparent damage and with no instrument.The swing tab was found to be in the unlocked position and with 5 drivers up along the staple line.The cartridge was tested for functionality with a test device and fired without any difficulties and the staples meet the staple form release criteria.However, 2 stapler were noted missing along the staple line.In addition, a tyvek returned along with the reload and the reload had some blood stains along the reload body.The event reported was confirmed and it is related to improper use of the device.As it is possible that the firing knob was not returned to its home position while loading the reload.It is possible that improper handling of the reload caused the staples to fell out, the proper handling instructions should be used when removing and reloading cartridges into the device, please reference the instructions for use.It should be noted that 100% inspection is performed by means of an automated vision system to ensure staples presence; the swing tab is present and unlocked.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 606d50, and no non-conformances related to the reported complaint condition were identified.Additional information was requested and the following was obtained: i have no new information to add to this complaint at this time.I will try and get some more of the requested information as soon as i can.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 unk procedure, the stapler reload came out of the package with loose staples as if it had already been used.No patient consequences were 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: 23838165
• Report Number: 3005075853-2025-09619
• Device Sequence Number: 5032258
• Product Code: GDW
• UDI-Device Identifier: 10705036003045
• UDI-Public: (01)10705036003045(17)300531(10)606D50
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/18/2025

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: TCR10
• Device Lot Number: 606D50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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