MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ENSEAL X1; Electrosurgical cutting & coagulation & accessories

Catalog Number	NSLX120L
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparotomy procedure the device was opened and the handle broke off.Opened a new device to continue operation.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/11/2026.D4 batch#: z7007e.Additional information was requested and the following was obtained: was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.Patient status/outcome/consequences? no.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the device was returned with no apparent damaged.Mechanical testing, it was observed the trigger loose causing the jaw to not close and open.The device was connected to a gen11 and it was recognized, due to the condition of the device returned not all functional testing could be performed.The device was disassembled to verify the condition of the internal components, and it was found that the firing mechanism was broken inside the shrouds.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.It is possible that excessive force in attempting to close the jaw may have caused this damage.A manufacturing record evaluation was performed for the finished device lot/batch z7007e, and no non-conformances were identified.

• Brand Name: ENSEAL X1
• Common Device Name: Electrosurgical cutting & coagulation & accessories
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Jabil (Tajuana)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50733473
• Report Number: 3005075853-2026-07472
• Device Sequence Number: 10574778
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: (01)10705036015024(11)300131(10)Z7007E
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K163548
• 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): 09/11/2026

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: NSLX120L
• Device Lot Number: Z7007E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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