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

Catalog Number	HAR23
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2026.D4 batch #: a97r6t.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 distal tip of the blade broken off and not returned.The remaining blade portion was scratched, with evidence of contact with metal in or out of the operative field.During functional testing on energy systems, an alert screen was displayed.A probable cause for the device to stop activating and the energy systems to display an alert screen is blade damage.The device was disassembled to verify the internal components and no anomalies were found.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure, or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage, which can result in activation issues such as failing the pre-run test with the generator and displaying an alert screen, including messages such as ¿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.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 batch a97r6t, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure the device was being plugged in and no response from the device.No set-up start and test activation when plugged in.Completely dead.Device was sterile and had to open another one to complete procedure.

• 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: 24957999
• Report Number: 3005075853-2026-03052
• Device Sequence Number: 5406783
• Product Code: LFL
• UDI-Device Identifier: 10705036014430
• UDI-Public: (01)10705036014430(17)300331(10)A97R6T
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120729
• 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): 04/22/2026

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: HAR23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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