MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 55MM SELECTABLE NEW TLC; STAPLE, IMPLANTABLE

Catalog Number	NTLC55
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, close staple height selector is broken.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4) date sent: 3/5/2026 b3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch # 326d36.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 ntlc55 device was received with the staple height selector from the both sides were broken, also one side was returned inside of plastic bag.And with no reload loaded in the device.Further analysis shows that the locks of anvil shroud were cracked and the anvil post on proxiaml end was damaged as if the anvil was pulled out off the device.No functional test was performed due to the condition of device.The event reported was confirmed and due to the condition of the staple height selector and the locks, 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 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 326d36, and no non-conformances were identified.Additional information was requested and the following was obtained: please provide the account/facility name 2.Did the damage occur right out of the packaging, during loading/unloading, or in the operative field? yes 3.Did the damage occur right out of the packaging or in the operative field? operative field.4.Did any piece's fall into the patient? no 5.If yes, were they retrieved? 6.Will all pieces be returned with the device? no 7.If no, were they discarded? yes 8.Could you please clarify if there were any patient consequences? no 9.Could you please clarify if there were any 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.

• Brand Name: 55MM SELECTABLE NEW TLC
• 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: 24521496
• Report Number: 3005075853-2026-01838
• Device Sequence Number: 18252590
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)291031(10)363D83
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 363D83
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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