MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLX137C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 5/28/2026.D4 batch #: unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information was requested and the following was obtained: what was the indication for the initial surgery? tah.What was the type of approach in the procedure? abdominal.Did the surgeon experience any device issues during the initial procedure? no.Which vessel was the device used on in the initial procedure? uterine artery.Was there any bleeding during the initial procedure? only during the cuff closure.Were there any coagulation issues during the initial procedure? no.What is the surgeon¿s experience with the enseal x1 curve jaw device? have used since february.How was the hematoma identified? er visit about 2 weeks post op.How was the hematoma addressed? iv antibiotics.Was a re-operation performed? no.What was the source of the bleeding and was it from a vessel that was sealed with the enseal device? vaginal cuff; no.What is the patient¿s current status? went to main vanderbilt ir dept.But had other issues, as well.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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.
Event or Problem Description
It was reported that after the unknown procedure, the patient developed hematomas postoperatively, approximately one week later.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/17/2026.Additional information was requested and the following was obtained: what was used to close the vaginal cuff? vicryl interrupted suture.Given the fact that it has been confirmed that there was no bleeding in the area the enseal was used, is there an alleged device deficiency with the enseal device? if not, can the complaint be voided? don¿t think there is an issue with the device, but i don¿t feel like i can say the void it or not.

• Brand Name: ENSEAL
• 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: 25318930
• Report Number: 3005075853-2026-04000
• Device Sequence Number: 5368203
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NSLX137C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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