MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 LARGE JAW TISSUE SEALER; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLX120L
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 1/26/2026.D4 batch #: y7054v.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.During 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.A video was provided and the condition of the reported event was shown.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 y7054v, and no non-conformances were identified.
Event or Problem Description
It was reported that during a vet procedure, on first use, the trigger dropped out and came loose, preventing it from closing.There were no patient consequences.

• Brand Name: ENSEAL X1 LARGE JAW TISSUE SEALER
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 24177189
• Report Number: 3005075853-2026-00783
• Device Sequence Number: 9486427
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: (01)10705036015024(17)290930(10)Y7054V
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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: Y7054V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown