MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. Enseal; Electrosurgical cutting & coagulation & accessories

Catalog Number	NSLX137C
Medical Device Problem Codes	Difficult to Open or Close (2921); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure initially the device was performing fine.Then after seal and press cut on the device, it stuck.Jaw failed to open on the device.Able to open the jaw of the device by force when outside of patient body, by inserting pull force on the closing handle.A bipolar and normal scissors were used to remove the device from the uterus.Another device was used to complete the surgery.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/17/2026.D4 batch#: unknown.Additional information was requested and the following was obtained: was there any reported patient or user harm? no.Was there a significant delay? no.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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: Enseal
• Common Device Name: Electrosurgical cutting & coagulation & accessories
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo Surgery, Inc. (Cincinnati)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50808371
• Report Number: 3005075853-2026-07672
• Device Sequence Number: 20968198
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: (01)10705036015468(11)280131(10)A9CA8C
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K172580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NSLX137C
• Device Lot Number: A9CA8C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2023
• 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
• Patient Sex: Unknown