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

Catalog Number	NTLC75
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Firing Problem (4011)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post op to a hemicolectomy there was an anastomotic leak.The anastomosis was side to side, to control the same suturing has been done.
Additional Manufacturer Narrative
(b)(4).Date sent 8/5/2026 d4 batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Additional information was requested, and the following was obtained: did any of the patients experience any clinical consequences because of the anastomotic leaks? yes all the three, they have to go for another surgery to close the anastomotic leak, by suturing.¿ what is the current clinical status of each patient? patients are stable any in ward, no discharge has been made.¿ was the hospital stay extended due to the reported events? if yes, please provide details regarding the duration and reason for the extension.Yes for one week, reason ¿ due to anastomotic leak.¿ were any additional interventions, procedures, or treatments required following the detection of the leaks?, leaks has been closed by hand suturing ¿ is there any relevant operative, postoperative, or imaging findings that may assist in the evaluation? yes.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: what color setting was selected on the device and what was the sequence of the firings? what anatomical structures was the device fired on? were other stapling or suturing devices used when creating the anastomosis? or can use these questions instead: what device was used to create the common channel? what was used to close the common opening? were there any issues experienced with the device in the initial surgical procedure? was the device difficult to fire? how were the post-operative issues identified? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe.Does the surgeon believe that these leaks are related to the device? any patient factors? 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: 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: 50144900
• Report Number: 3005075853-2026-06322
• Device Sequence Number: 10687218
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)300831(10)769D45
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NTLC75
• Device Lot Number: 769D45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 08/12/2026; 09/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/17/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female