MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 25CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLX125C
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	03/13/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a segmentectomia a thin vessel was sealed with cove and after 24-hours massive bleeding occurred.When opening the patient, it was identified that the sealed vessel was open.The patient died.
Additional Manufacturer Narrative
B)(4).Date sent: 4/1/2025.D4 batch #: unknown.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 is the surgeon's experience with device? what was the indication of the original procedure? please provide a timeline of all of the events.Were there any issues with hemostasis intra-op of the original procedure? did the patient have any prior chemotherapy or radiation? was the patient on an anti coagulation regime? where was the location of the vessel? was the vessel under tension when sealed? was it a thin-walled vessel or thin width vessel? what was the approximate width of the compressed vessel? was the vessel skeletonized or as part of a bundle when it was sealed? was the completion tone heard on the firing on the affected vessel? were there any generator alert screens during the original procedure? can the generator log be downloaded and provided for engineering review? how was bleeding identified post procedure? what was done in attempt to control the bleeding? was an autopsy performed? if yes, can the autopsy be provided to ethicon? what was the cause of death? is the surgeon interested in having a call with ethicon medical and engineering? 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2025.Additional information was obtained: according to the sales rep responsible for creating this complaint, (b)(4) refers to the same patient as (b)(4).Therefore, product code nslx125c batch c9el72 must be added to (b)(4) must be voided.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.See related report number: 3005075853-2025-02844.

• Brand Name: ENSEAL X1 CURVED 25CM SHAFT
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (CINCINNATI)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21742520
• Report Number: 3005075853-2025-02427
• Device Sequence Number: 19870582
• Product Code: GEI
• UDI-Device Identifier: 10705036015444
• UDI-Public: (01)10705036015444(17)290630(10)C9EL72
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K172580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: NSLX125C
• Device Lot Number: C9EL72
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown