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	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/26/2026.D4 batch#: a97n8u.Investigation summary - the product was returned for evaluation.Visual analysis of the returned sample determined that the device was returned with the blade scratched and cracked.During functional testing to the energy system, an alert screen was displayed.The device was analyzed, and it was determined that it was used in more than one generator.The device is intended to be used with a single generator.If the device is connected to a different generator an alert screen will be displayed indicating to replace instrument / no instrument uses remaining / restart generator.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.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.Continued usage of the damaged blade can result in a broken blade.This device is packaged and sterilized for single use only.Multiple patient use may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.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 a97n8u, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported that, during a coronary artery bypass grafting the ¿relax pressure on blade¿ was displayed in the middle of use.The problem did not improve even after setting it again, and ¿replace instrument¿ was displayed in the end.The same problem occurred in the middle of use even after replacing it with a new one, so it was switched to a new handpiece, the situation was not changed.A third handpiece and a third disposal device were taken out.After that the problem did not occur.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: 25636637
• Report Number: 3005075853-2026-05013
• Device Sequence Number: 15834210
• Product Code: LFL
• UDI-Device Identifier: 10705036002819
• UDI-Public: (01)10705036002819(17)300228(10)A97N8U
• 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): 06/26/2026

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: 04/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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