MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	NTLC75
Medical Device Problem Codes	Failure to Fire (2610); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the surgeon noticed there is misalignment of the left and right side anvil.After attached together, the blade was seen exposed in between firing handle and the knife couldn¿t advance for firing.Was there any reported patient or user harm? no.Was there a significant delay? no.
Additional Manufacturer Narrative
(b)(4).Date sent 9/17/2026.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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 information was requested, and the following was obtained: were there any adverse event/patient consequences in this case? ans: nope.Did the same issue happened for both devices? ans: yes.2.If not, did the device lock-out (no staples deployed and no cut line started)? ans: yes.3.Or, did the device start to deploy staples and cut but could not be completed? ans: never deployed stapler at all.4.Were any staples delivered into the tissue at all? ans: no.5.What was the appearance of the deployed staples (b-formed, malformed, goal post/legs straight)? ans: no staplers deployed.6.Were there staples missing from the staple line (staples not present/visible on any portion of the staple line)? ans: no.7.Did the device cut the tissue? ans: no.8.If the device cut, was the cut line complete? ans: no cutting.9.How was the issue addressed? ans: not using staplers, surgeon handsaw.10.Please provide the source or title of external person providing answers to follow-up, e.G.Nurse, surgeon, etc.Ans: - surgeon.11.Device follow-up: is the product still available for return? if yes, please drop at the office or courier back the sample using gdex to j&j pinnacle office.Ans: - yes.A video was received.Any additional information obtained from the video evaluation will be included as part of the product investigation.

• Brand Name: N/A
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50801643
• Report Number: 3005075853-2026-07627
• Device Sequence Number: 20993499
• Product Code: GDW
• UDI-Device Identifier: 10705036002628
• UDI-Public: (01)10705036002628(17)310131(10)917D58
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K092577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial

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: NTLC75
• Device Lot Number: 917D58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2026
• 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