MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 35CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLG2C35
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 2/27/2026 d4 batch #: a9e85h.Investigation summary the product was returned for evaluation.Visual analysis of the returned sample revealed that the device was received with no apparent damage.The device was tested with a generator; the hand activation was not functional.However, the device worked properly with the footswitch.The device was disassembled to verify the condition of the internal components, and it was noted that the hand activation switch button was damaged.This caused the hand activation failure.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch a9e85h, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what caused this issue.
Event or Problem Description
It was reported that during a gastric resection there was an error due fault button.The procedure was delayed 10 minutes but was completed successfully.There were no patient consequences.

• Brand Name: ENSEAL G2 CURVED JAW 35CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 24470072
• Report Number: 3005075853-2026-01642
• Device Sequence Number: 18699592
• Product Code: GEI
• UDI-Device Identifier: 10705036014140
• UDI-Public: (01)10705036014140(17)281031(10)A9E972
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: NSLG2C35
• Device Lot Number: A9E972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown