MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC 700 SHEARS 45CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR745
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pleural Effusion (2010); Pneumonia (2011); Unspecified Tissue Injury (4559)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that for a clinical trial patient (b)(6) during a upper gastrointestinal procedure the patient experienced subcutaneous emphysema of the chest wall, dysphagia, pneumonia, and left pleural effusion.The subcutaneous emphysema of the chest wall has a causal relationship with the procedure and not related to the device.The dysphagia has a causal relationship with the procedure and not related to the device.The pneumonia has a possible relationship with the procedure and not related to the device.It was treated with drug therapy.The left pleural effusion has a causal relationship with the procedure and not related to the device.It was treated with a pigtail chest tube installation.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/9/2025 d4 batch #: y70617.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, and with evidence of contact with metal in or out of the operative field.In addition the device was returned with the clamp arm damaged from the inner tube, but firmly fixed to the outer tube at the clamp arm weld.During functional testing on gen11, 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.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.Possible causes of the clamp arm damage are not closing the clamp when sliding the torque wrench on and off; not closing the clamp when introducing or removing through the trocar; or possible entanglement in fibrous tissue.Based on the evidence, the issues with the har745 device (damaged clamp arm and broken blade) do not appear to be related to the reported case of subcutaneous emphysema.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 number y70617, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/24/2025.Additional information was obtained: adverse event term: subcutaneous emphysema of the chest wall.End date: blank: (b)(6) 2025.Outcome: not recovered/not resolved.Recovered/resolved without sequelae.Adverse event term: dysphagia.End date: (b)(6) 2025, blank.Outcome: recovered/resolved without sequelae, not recovered/not resolved.

• Brand Name: HARMONIC 700 SHEARS 45CM
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22166263
• Report Number: 3005075853-2025-04273
• Device Sequence Number: 9401782
• Product Code: LFL
• UDI-Device Identifier: 10705036035787
• UDI-Public: (01)10705036035787(17)291130(10)Y70617
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: HAR745
• Device Lot Number: Y70617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE AND GENERATOR
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 94 KG