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

Catalog Number	TLC75
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 2/20/2026 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.Additional information was requested and the following was obtained: procedure: ileostomy reversal they tried to form the new anastomosis with use of the tlc75.Although not all staples were fired while the intestine was cut along the entire length that can be provided with the tlc.Resulting in a partially unclosed intestine.Luckily, they saw this on time and were able to suture the part of the intestine that was not stapled with the tlc.For safety, they also sutures the part of the intestine that was staples, since they didn¿t trust the formed staple line anymore and therefore, the surgery took more time than expected.Since they saw the problem on time, there were no consequences for the patient.The tissue they staples showed no particularities, so this could not be the reason the stapler didn¿t staple the remaining part.Is the current patient status known? no was there any patient consequence or change in the post-operative care of the patient as a result of the event? no 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 ileostomy reversal the staples at the end of the staple line were not fully closed.Therefore, the tissue layers were not fully closed.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/3/2026.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 # 682d88.Investigation summary: the product was returned to ethicon endo-surgery for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample revealed that the tlc75 device was received with no apparent damage, with no reload present.The device was tested for functionality with a test reload and it fired, cut, and formed all the staples as intended.The staple line and cut line were complete, and the staples meet the staple form release criteria.The event described could not be confirmed as the device was returned without detectable damage.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 682d88, and no non-conformances related to the reported complaint condition 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: 24405414
• Report Number: 3005075853-2026-01511
• Device Sequence Number: 21360666
• Product Code: GDW
• UDI-Device Identifier: 10705036013211
• UDI-Public: (01)10705036013211(17)300731(10)701D76
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: TLC75
• Device Lot Number: 701D76
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/07/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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