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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/30/2026.D4 batch #: unknown.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.
Event or Problem Description
It was reported that, during a laparoscopic nephroureterectomy, the jaws became not open and the boundary with the shaft is damaged.(report of malfunction from operating room staff.) the surgeon has moved on to the next surgery, so the detailed situation is unknown.The jaws of the product are not opening, and something like a tissue is stuck in it.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/16/2026.D4 batch #: a99c3m.Additional information was obtained: the tissue was removed.Since it was a non-critical area, there were no particular problems.The procedure is a laparoscopic nephroureterectomy for malignant tumor.The device was used for the perinephric tissues.There is no impact on the patient after surgery.It is unclear what kind of procedures were performed.It is unknown whether the shaft broke first, preventing the jaws from opening, or vice versa.It seems that there were no broken pieces.No remains in the patient.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the device was returned with the distal guide weld broken.Due to the several damaged, no functional testing could be performed.The jaws were unable to open and close.Additionally, photo was provided and they showed the condition of the reported event.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.Please refer to the ifu for proper handling of the device, note that ¿caution: do not grasp tissue beyond the electrode surface, in the hinge of the jaws.Do not overfill the jaws of the instrument with tissue.This could result in difficulty opening the jaws, partially cutting tissue, and unintended injury.

• 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: 24733979
• Report Number: 3005075853-2026-02371
• Device Sequence Number: 15763495
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: (01)10705036015468(17)301130(10)A99C3M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: A99C3M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• 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