Harmonic ACE

Description of Event or Problem

It was reported that during an unknown procedure the scalpel was hard to cut. 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: (b)(6) 2026.D4 Batch#: Z7035A.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 HARH36 device was returned with the distal tip of the blade broken off and not returned. The remaining blade portion was scratched, and with evidence of contact with metal in or out of the operative field.During functional testing to the Energy System, an alert screen was displayed. A probable cause for the device to stop activating and the GEN11 to display an alert screen is blade damage.Due to the condition of the returned device, we were unable to test for the reported Tissue Effect Issues.The device was disassembled to verify 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 ¿Tighten Assembly¿, ¿Blade Error Detected¿ or "Relaxed Pressure on Blade" followed by a ¿Replace Instrument¿ screen later in the procedure. Continued usage of the damage blade can result in a broken blade.As part of Ethicon Endo Surgery quality process all devices are manufactured, inspected, and released to approved specifications. A manufacturing record evaluation was performed for the finished device lot/batch Z7035A, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by Ethicon, or its employees that the report constitutes an admission that the product, Ethicon, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.