MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 20CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HARHD20
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/17/2025.D4 batch#: y7046l.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: did the active titanium blade break off? did the white tissue pad break off? is the white tissue pad completely missing from the clamp arm of the device? did the patient experience any adverse consequences due to this issue? 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 tissue pad was damaged with a staple imbedded.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 ¿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.If the device is activated across a clip, staple line, or other metal in the jaws, the blade and the tissue pad 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.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: y7046l, and no non-conformance's were identified.
Event or Problem Description
It was reported that during an unknown procedure the device cannot be activated, coating cracked, no residue found at the broken end.Changed to another one to complete surgery.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/20/2026 additional information was requested and the following was obtained: did the active titanium blade break off? -yes did the white tissue pad break off? -no is the white tissue pad completely missing from the clamp arm of the device? -no did the patient experience any adverse consequences due to this issue? -no corrected data: h6 medical device problem code.

• Brand Name: HARMONIC HD 1000I SHEARS 20CM SHAFT
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 23830040
• Report Number: 3005075853-2025-09598
• Device Sequence Number: 13080874
• Product Code: LFL
• UDI-Device Identifier: 10705036015048
• UDI-Public: (01)10705036015048(17)290731(10)Y7046L
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: HARHD20
• Device Lot Number: Y7046L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown