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

Catalog Number	HAR1136
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the ¿replace instrument¿ alert screen was displayed.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: 9/24/2026.D4 batch#: z7035r.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 the distal tip of the blade broken off and not returned.The remaining blade portion was scratched, with evidence of contact with metal in or out of the operative field.The device was also returned with the tissue pad damaged and 100% present.During functional testing on energy systems, an alert screen was displayed, and the device did activate during functional testing.A probable cause for the device to stop activating and the energy systems to display an alert screen is blade damage.The device was disassembled to verify the internal components and 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, 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 ¿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.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Prolonged usage of advanced hemostasis mode may cause tissue pad damage.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot/batch z7035r, 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: 50885213
• Report Number: 3005075853-2026-07967
• Device Sequence Number: 10744763
• Product Code: LFL
• UDI-Device Identifier: 10705036026167
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200841
• 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): 09/24/2026

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: HAR1136
• Device Lot Number: Z7035R
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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