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

Catalog Number	TX30B
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/5/2026.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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide more details about the device quality issue? did the damage occur right out of the packaging, during loading/unloading, or in the operative field? was the plastic portion of the cartridge damaged? or did the metal pan separate from the device? if yes, did the piece fall in the patient, and if so, was it retrieved? were any staples delivered into the tissue at all? what was the appearance of the deployed staples (b-formed, malformed, goal post/legs straight)? were there staples missing from the staple line (staples not present/visible on any portion of the staple 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 an urology case overnight.The first blue was fired and then a white 30v reload was asked for.The surgeon asked for additional reloads and staplers to be opened and attempted one firing on the specimen before realizing that the 30 vascular reload was not compatible with the regular tx handle.It was noted upon picking up the product that two of the white vascular loads were missing the bottom plastic piece that keeps the retaining pin in place.It was thrown out intra-operatively after the nurses tried to remove the unfired reloads from the stapler.No consequence to the patient.The specimen's malformed staple line was oversewed using suture.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/2/2026.The device/photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/16/2026.D4: batch # 416d82.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 tx30b device was received with no apparent damage and a xr30v reload loaded on the device.The reload was received fully fired.The device was tested for functionality with a reload xr30b and it fired and formed all the staples as intended.The staple line was complete, and the staples meet the staple form release criteria.The event reported was confirmed and the condition of the reload received is related to improper use of the reload.It should be noted that a xr30v (white vascular) reload is only designed to work on a tx30v device.The blue (standard) and green (thick) reloads can be used interchangeably with the appropriately sized instruments.The white (vascular) reload is dedicated to the 30 mm vascular linear stapler and is not interchangeable with the blue and green reloads.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 416d82, 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: 24524363
• Report Number: 3005075853-2026-01856
• Device Sequence Number: 9723886
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: (01)10705036003311(17)291231(10)434D23
• 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,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 434D23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 04/07/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/02/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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