MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. DUALTO Energy System; Electrosurgical Cutting and Coagulation Instruments

Catalog Number	ETHEM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure, the patient developed hematoma in their leg following use of the dualto device.No additional information was provided regarding the event, severity of the hematoma, or any medical interventions required.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/1/2026.Additional information was requested and the following was obtained: do you know if the healthcare professional experienced any issues with the dualto during either case prior to the development of the hematomas? if yes, what were the issues? -the setting on the dualto did not appear to be high enough.During a cabg procedure, the physician assistant (pa) was using a terumo device with the harvester and the dualto system and was not receiving adequate current to the bipolar device.The pa reported that only minimal current was present.The device was disconnected from the dualto system and connected to an ft10 competitor device.
Additional Manufacturer Narrative
(b)(4) date sent: 8/5/2026 d4 batch #: unknown d4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what generator settings were used? is there an event log available? please send to productcomplaint1@its.Jnj.Com an analysis of the product could not be performed since a physical sample was not received for evaluation.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.

• 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 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50142747
• Report Number: 3005075853-2026-06298
• Device Sequence Number: 10746115
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 10/01/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown