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

Catalog Number	HARHD36
Medical Device Problem Code	Difficult or Delayed Activation (2577)
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 could not be activated.Changed to another device to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4) date sent: 9/30/2026 d4 batch#: z7027c.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.The device was returned with the clamp arm detached and not returned.Additionally, the blade tip was damaged, however, the blade was not cracked.The device was connected to a test hand piece and an energy systems and the device did activate during functional testing.Due to the device returned condition, not all functional testing could be performed with the generator.The device was disassembled to verify the condition of the internal components, and no anomalies were found.If the device is activated across a clip, staple line, or other metal in the jaws, the blade could get damaged, subsequent activations may increase the severity of the blade damage.Once minor blade damage has occurred 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 ¿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.Possible causes of the clamp arm damage are not closing the clamp when introducing or removing through the trocar, or possible entanglement in fibrous tissue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ees quality system.A manufacturing record evaluation was performed for the finished device lot/batch z7027c, and no non-conformances were identified.

• Brand Name: Harmonic
• 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: 50948444
• Report Number: 3005075853-2026-08133
• Device Sequence Number: 10446700
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160752
• 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): 09/30/2026

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: HARHD36
• Device Lot Number: Z7027C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/20/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown