MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	NTLC55
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 5/25/2026 b3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch # 216d29.Investigation summary the product was returned to ees for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that one ntlc55 device was returned with the staple height selector loose, no reload present, and the anvil shroud showed one locks damaged that support the metal body anvil to shroud causing easy movement of the metal body.This condition most likely caused the staple height selector damage.Further analysis shows the anvil partially detached from the distal end side and the anvil post on this area appears to be damaged as if the anvil was pulled out off the device.No functional testing was performed due to the observed damages, including the loose staple height selector, anvil damaged, and broken locks on the anvil shroud, which would prevent proper device operation.Based on the condition of damages observed in the device, the reported complaint was confirmed by an external cause as improper handling.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.Please reference the instruction for use for more information.As part of ees 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 216d29, and no non-conformances were identified.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 device lock-out (no staples deployed and no cut line started)? or did the device start to deploy staples and cut but could not be completed? 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)? did the device cut the tissue? if the device cut, was the cut line complete? how was the issue addressed? was there a patient consequence? if yes, how was the issue addressed? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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 unk procedure, the device was not working.No further details were provided.No patient consequences reported.

• Brand Name: N/A
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 25270506
• Report Number: 3005075853-2026-03859
• Device Sequence Number: 15749551
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)290731(10)216D29
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092577
• 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
• Report Date (Section B): 05/25/2026

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: NTLC55
• Device Lot Number: 216D29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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