MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. Harmonic ACE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR36
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the device shows multiple errors "replace instruments" and "identifying device".Completed the procedure with the help of another device.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4) date sent: 9/28/2026 d4 batch#: a97v33.Additional information was requested and the following was obtained: was surgery delayed due to the reported event? yes, if yes, number of minutes: 20, was procedure successfully completed? yes were fragments generated? no if yes, were they removed easily without additional intervention? no patient status/ outcome / consequences no was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no 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 analyzed, and it was determined that it was possibly used in more than one procedure, based on generator data.The device is intended and labeled for single patient use.If the device is connected to multiple generators, an alert screen will be displayed indicating ¿adaptive tissue technology features are not available in this device¿.Due to the multiple generator usage, 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.No communication issues were observed at any time during the testing.The device was disassembled to verify the condition of 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.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 ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.This device is packaged and sterilized for single use only.Multiple patients uses may compromise the device's integrity or create a risk of contamination that, in turn, may result in patient injury or illness.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot/batch a97v33, and no non-conformances were identified.

• Brand Name: Harmonic ACE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 50916665
• Report Number: 3005075853-2026-08027
• Device Sequence Number: 5803754
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: A97V33
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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