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

Catalog Number	HAR36
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 6/15/2026 d4 batch #: a97z2x.Additional information was requested and the following was obtained: did the generator display any error messages and if so, what were they? ¿ no message, touch screen not working did the device pass the pre-test? -- nothing would happen because touch screen is not working had the device been working and then stopped? ¿device is working when start but when we touch the screen it is not working.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 the blade tip damaged, however, the blade was not cracked.The device was connected to a test handpiece on the energy system.During functional testing, it was noted that the hand activation buttons were nonfunctional.However, the device did activate when tested with the footswitch.The device was disassembled to verify the condition of the internal components.Corrosion was found at the hand activation domes.If the device is activated across a clip, staple line, or other metal in the jaws, the blade could get damaged, subsequent activations may increase the severity of the blade damage.Once minor blade damage has occurred 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.Due to the moisture discovered on the instrument, which is evidence of possible reuse, we are unable to determine how this condition impacted the performance of the device and, therefore, cannot conclude the root cause.Our manufacturing, sterilization, packaging, and shipment processes do not introduce corrosion/moisture to the device.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 a97z2x, and no non-conformances were identified.
Event or Problem Description
It was reported that after an unknown procedure the device was not working.No consequences to patients.

• 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: 25510527
• Report Number: 3005075853-2026-04596
• Device Sequence Number: 21456951
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• UDI-Public: (01)10705036014447(17)300430(10)A97Z2X
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: HAR36
• Device Lot Number: A97Z2X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown