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

Catalog Number	TX30B
Medical Device Problem Codes	Failure to Form Staple (2579); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open lar, tx30b was fired.However, when leak test was performed, it is found that the staple line was loose in the middle.Surgeon mentioned that the staples did not capture the tissue fully in the middle but there were dog ears at the side.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4) date sent: 3/23/2026 d4: batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was obtained: 1.Was there a change in the procedure? if yes, please explain.1.No 2.Could you please clarify if there were any patient consequences? 2.No patient consequences 3.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 3.No post op care dog ears at the side means the staple line at the two ends were secure but the middle is loose.Surgeons suture over the staple line in the same procedure after finding out that the staple line is loose.Surgery was delayed for around 30 mins as they had to suture over staple line.Procedure was successfully completed and the patient is in recovery now.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/13/2026.D4: batch # 450c73.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 revealed that the tx30b device arrived with no apparent damage and with a xr60b reload loaded on the device.The reload was received fully fired.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The staple line was complete, and the staples meet the staple form release criteria.In addition, a tyvek returned along with the device.The event described could not be confirmed as the device performed without any difficulties noted.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 450c73, and no non-conformances were identified.

• Brand Name: PROXIMATE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 24666875
• Report Number: 3005075853-2026-02184
• Device Sequence Number: 5067417
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: (01)10705036003311(17)280531(10)473C82
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 04/13/2026

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: TX30B
• Device Lot Number: 473C82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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