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

Catalog Number	ETHUSC
Medical Device Problem Codes	Arcing of Electrodes (2289); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a total laparoscopic hysterectomy with bilateral salpingectomy for uterine fibroids, bleeding from the port site was cauterized using a right-angle electrode of the probe plus during wound closure.An electric current ran through the muscle retractor that was placed in the surgical field at that time, causing a second-degree burn.The attending physician's opinion is that it may have been an electrical discharge.The patient is female, but it is currently confirming the treatment she received for this incident, her condition after treatment, and the patient background information.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/14/2026.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.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 were the generator settings for the connected probe plus device? what is the user¿s experience with the probe plus device? were there any other functional issues with the dualto or probe plus during the procedure? what return electrode was used and the location of the electrode? how was the bleeding from the port site addressed? at what point during the procedure did the electric current event occurred? what actions were being performed at the time of the burn? can an image/photo of the muscle retractor that was used in the procedure be shared? can an image/photo of the patient burn be shared? how was the patient treated? what is the patient's current status? can the event log for the dualto be shared for engineering review? what were the serial numbers of each of the dualto components? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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: 50255811
• Report Number: 3005075853-2026-06679
• Device Sequence Number: 10135058
• Product Code: GEI
• UDI-Device Identifier: 20705036038372
• UDI-Public: 20705036038372
• 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: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: ETHUSC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/31/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/02/2026
• 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: Required Intervention
• Patient Sex: Unknown