MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. DUALTO ENERGY SYSTEM; ELECTROSURGICAL CUTTING AND COAGULATION INSTRUMENTS

Catalog Number	ETHEM
Medical Device Problem Codes	Self-Activation or Keying (1557); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/15/2026.D4 batch #: unknown.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.Additional information was requested and the following was obtained: i do not have the enseal for return or the lot number.Nslx145c 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 lap sleeve gastrectomy, they had completed use of enseal x1, he was changing instruments and randomly an "energy module error" screen popped up.The screen was frozen for about 10 seconds and then it cleared.After the error disappeared, the enseal started activating with no one touching the seal button while sitting on the mayo stand and went on activating until they pulled the plug on the generator after about 10 seconds.They restarted the generator and everything worked fine; the case was finished with no patient harm.

• Brand Name: DUALTO ENERGY SYSTEM
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION INSTRUMENTS
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 25183445
• Report Number: 3005075853-2026-03673
• Device Sequence Number: 10385126
• Product Code: GEI
• UDI-Device Identifier: 20705036038389
• UDI-Public: 20705036038389
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: ETHEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown