MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. WHITE RELOAD FOR ECHELON 45; STAPLE, IMPLANTABLE

Catalog Number	ECR45W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post op to a laparoscopic lobectomy thoracic procedure, bleeding on the second postoperative day.Emergency thoracoscopic exploration, thoracic blood clot debridement, hemostasis.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 10/28/2025.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: how was the post-op bleeding identified? drainage.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? clip was used.What was the pre and postoperative anti-coagulant and pain management protocol? unknown.Was the bleeding intraluminal or extraluminal? intraluminal.Were the staples the appropriate b-shape form? unknown.Any clips, clamps, or graspers near the area where the device was being fired? 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 45
• 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: 23403911
• Report Number: 3005075853-2025-08332
• Device Sequence Number: 11993955
• Product Code: GDW
• UDI-Device Identifier: 10705036001768
• UDI-Public: (01)10705036001768(17)271130(10)225C35
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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 Catalogue Number: ECR45W
• Device Lot Number: 225C35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• 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: Unknown