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

Catalog Number	PPH03
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993); Firing Problem (4011)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/3/2026.D4: batch#: unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information was requested and the following was obtained: 1.What confirmation was received that the device was fully fired? yes, with more resistance than usual in closure phase.2.Where within the gap setting scale was the orange indicator prior to firing? inside the green area with more resistance than usual in closure phase 3.Did the device cut? si.4.If the device cut was the cut line fully circumferential around the target tissue? yes.5.Did the device staple? yes.6.How many counter-clockwise revolutions were used to open the device? 3.7.Was the safety reset before removal attempted? yes.8.How many counter-clockwise revolutions were used to open the device? 3.9.How was it confirmed that the anvil was free from the tissue prior to removing? no answer received.10.After firing was the adjusting knob turned ½ to ¾ revolutions? no answer received.11.Was the device rotated 90 degrees in both directions to ensure the anvil was free from the tissue? yes.12.Was the safety reset prior to removal? yes.13.What was the users experience with the device? rigid firing cycle with suture line not above the toothed line.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 a prolapse, stapler blocked during insertion.In a longo surgery.It was needed to resect the tissue in a very low position to complete the surgery.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/7/2026.D4: batch # 434d42.An analysis of the product could not be performed since a physical sample was not received for evaluation.Device history review: a manufacturing record evaluation was performed for the finished device batch number of 434d42 / 18pph03 , 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: 24498025
• Report Number: 3005075853-2026-01718
• Device Sequence Number: 13251814
• Product Code: GDW
• UDI-Device Identifier: 10705036013006
• UDI-Public: (01)10705036013006(17)300131(10)434D42
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K051301
• 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): 05/07/2026

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: PPH03
• Device Lot Number: 434D42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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