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

Catalog Number	SNGHK
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/24/2026 d4 batch#: a9892u 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 tested on generator and it was found that the max and min hand control switch assembly buttons were not functional.However, it worked properly with foot switch assembly.The device was disassembled to verify the condition of the internal components.During analysis, moisture was discovered in the instrument.Since we are unable to determine how this condition impacted the performance of the device, we cannot determine root cause of the issue associated with this inquiry.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Our manufacturing, sterilization, packaging, and shipment processes do not introduce corrosion and/or moisture to the device; the moisture may be evidence of reuse or reprocessing.Please notify us of any processes or conditions that could have contributed to the moisture discovered in the instrument.A manufacturing record evaluation was performed for the finished device batch a9892u, and no non-conformances were identified.
Event or Problem Description
It was reported that, during an unknown cardiovascular surgery, ¿two switch activations detected¿ was displayed during connecting.The device was not used for the patient.Gen11 was used.The number of remaining uses was unknown.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: HARMONIC SYNERGY
• 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: 25611068
• Report Number: 3005075853-2026-04920
• Device Sequence Number: 5357909
• Product Code: LFL
• UDI-Device Identifier: 10705036002819
• UDI-Public: (01)10705036002819(17)300730(10)A9892U
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053056
• 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): 06/24/2026

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: SNGHK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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