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	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the or team is complaining about an ultracision handpiece with the error message "two button activation." there were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/12/2026.D4 batch#: a98h59.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 on the energy system.During functional testing, it was noted that the max hand activation button was 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 max hand activation dome.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 a 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: a98h59, and no non-conformance's were identified.

• 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: 25491417
• Report Number: 3005075853-2026-04553
• Device Sequence Number: 10439213
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• UDI-Public: (01)10705036014447(17)300630(10)A98H59
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: A98H59
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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