MAUDE Adverse Event Report: ETHICON INC. PROXIMATE; STAPLE, IMPLANTABLE

Model Number	TLC10
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After using proximate tlc10 stapler 100mm linear cutter, noticed 1/3 of the staples had not engaged on one of the staple loads.

• Brand Name: PROXIMATE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 us highway 202 s.; raritan NJ 08869
• MDR Report Key: 23756548
• Report Number: 23756548
• Device Sequence Number: 21355086
• Product Code: GDW
• UDI-Device Identifier: 10705036003120
• UDI-Public: (01)10705036003120(17)290430(10)C9E607
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2025
• Report Date (Section F): 11/05/2025

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
• Device Model Number: TLC10
• Device Catalogue Number: TLC10
• Device Lot Number: C9E607
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Date Report Sent to FDA: 11/05/2025