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

Catalog Number	HARH23
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/11/2026.D4 batch #: a98z4e.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 was returned with the blade tip broken off and not returned.Additionally, photos were provided and they are not related.During functional testing to the energy system, an alert screen was displayed.A probable cause for the device to stop activating and the gen11 to display an alert screen is blade damage.The device will stop activating when the blade becomes damaged.The device was disassembled to verify the blade and the blade breaking point was located at an area inside the tube proximal to the tissue pad.This is consistent with a side load being applied to the blade while active with the jaw closed.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result in activation issues such as failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.No conclusion could be reached as to how the blade crack issue occurred.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.
Event or Problem Description
It was reported that during an unknown procedure the ¿relax pressure on blade¿ alert screen displayed by the generator.Changed to another device to complete surgery.There was no patient consequence reported.No additional information can be provided.

• 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: 25136645
• Report Number: 3005075853-2026-03535
• Device Sequence Number: 9454428
• Product Code: LFL
• UDI-Device Identifier: 10705036014676
• UDI-Public: (01)10705036014676(17)300930(10)A98Z4E
• 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): 05/11/2026

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: HARH23
• Device Lot Number: A98Z4E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2025
• 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
• Patient Sex: Unknown