MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HARH23
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 6/10/2026.D4 batch #: a99793.Additional information was requested and the following was obtained: how was the bleeding controlled? -compression was there any other action taken for the procedure? -unknown did the procedure have to be converted to open? -yes did the patient need to have a blood transfusion? -no did the patient need any different type of post op care due to the bleeding/oozing? -no was there any patient consequence or change in the post-operative care of the patient as a result of the event? -no what were the indications for surgery? -invasive squamous cell carcinoma of the cervix what surgical procedure was performed? -radical hysterectomy for invasive cervical squamous cell carcinoma was it originally an open procedure? -yes at what point in the procedure did the device issues occur? -treat vessel which vessel was the device being used on when the issue occurred? -unknown what alert screens were seen during the procedure? -press ""ok"" can a generator log be provided for engineering review? -no what is the patient¿s current status? -discharged.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 damage.The device was connected to a test handpiece and tested to the energy system.The device was functional and worked as intended.There were no anomalies noted with the functionality of the device.The device was disassembled to verify the condition of the internal components, no evidence was found that could have caused the reported activation issues.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot/batch a99793, and no non-conformances were identified.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 the unknown surgery, the blade stopped working suddenly, with no power output.Tried to reconnect and change the hp, the blade still did not work.During the event, the patient experienced bleeding, blood pressure decreasing, and heart rate increasing.Finally, changed a new device to continue the operation.The surgery was delayed about 1 hour.

• Brand Name: HARMONIC ACE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 25462148
• Report Number: 3005075853-2026-04315
• Device Sequence Number: 10363061
• Product Code: LFL
• UDI-Device Identifier: 10705036014676
• UDI-Public: (01)10705036014676(17)301130(10)A99793
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132612
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: HARH23
• Device Lot Number: A99793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown