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	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 8/11/2025.D4 batch # 236d84.B3: unknown; captured as awareness date.Investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample revealed that the tcr10 reload was received with 5 most proximal drivers up with 2 partially formed staples and the swing tab was noted to be missing, making the reload nonfunctional.Also 1 missing staple was noted missing along the staple line in the reload.It is possible that an improper handle of the reload caused that the staple come out of the pockets.In addition, a slight damage was noted where the swing tab is placed and one missing staple was.Due to the condition of the reload no functional test was performed.No conclusion could be reached on what caused the swing tab to detach.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, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 236d84, and no non-conformances were identified.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during an unknown procedure, the device could not be fired.The device was routinely used in this facility.There was no effect on the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: 22771355
• Report Number: 3005075853-2025-06340
• Device Sequence Number: 9342401
• Product Code: GDW
• UDI-Device Identifier: 10705036003045
• UDI-Public: (01)10705036003045(17)290731(10)236D84
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/11/2025

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: 236D84
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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