MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. WHITE RELOAD FOR ECHELON 60; STAPLE, IMPLANTABLE

Catalog Number	ECR60W
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Hemorrhage/Blood Loss/Bleeding (1888); Pulmonary Edema (2020)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the unk procedure of wedge resection of the lung, noted the staples malformed.After the procedure, noted the patient had pulmonary edemalight with serious bleeding and air leakage.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 5/9/2025 d4: batch # unk.Investigation summary: this is an analysis of photo submitted to ethicon endo-surgery for evaluation.During the visual analysis, the following was observed: the photo shows a tomography that does not provide enough information related to the report event.Based on the photo the event described could not be confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.An analysis of the product could not be performed since a physical sample was not received for evaluation.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: what were the indications for surgery? unknown.What surgical procedure was performed? pulmonary lobectomy.Did the patient receive any preoperative chemotherapy or radiation? unknown.How was the post-op bleeding identified? ct showed edema.How many days postoperative was the bleeding identified? unknown.What was the total estimated blood loss (ml)? unknown.Was a transfusion required? no.How was the bleeding addressed? suture sewing.What was the pre and postoperative anti-coagulant and pain management protocol? unknown.Was the bleeding intraluminal or extraluminal? intraluminal.Was an interoperative leak test performed? unknown.For how long after the procedure, did the patient experience an air leak? unknown.Were there any issues experienced with the device in the initial surgical procedure? malformed staples.What was the quality of the lung tissue observed at the time of the procedure? unknown.Were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.Malformed staples after fire.Was there noted intraoperative bleeding from the staple line? yes.What was done surgically to address the malformed staples in the initial procedure? suture sewing.What device was used to fire the cartridges? ec60a.What is the lot/batch number of the device(s) used? unknown.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: WHITE RELOAD FOR ECHELON 60
• 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: 21997833
• Report Number: 3005075853-2025-03519
• Device Sequence Number: 15645815
• Product Code: GDW
• UDI-Device Identifier: 10705036001799
• UDI-Public: (01)10705036001799(17)260630(10)519C13
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051002
• 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): 05/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: ECR60W
• Device Lot Number: 519C13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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
• Patient Sex: Male