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

Catalog Number	HARHD20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/1/2025.D4 batch #: unknown.Additional information was requested and the following was obtained: did the active titanium blade break off? yes.Were any fragments generated? yes.Did the fragments generated fell off inside the patient? yes.If yes, were they completely removed from the patient without additional intervention? yes.What efforts were made to locate the pieces of the blade during the procedure? unknown.Did the patient experience any adverse consequences due to this issue? no.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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.
Event or Problem Description
It was reported that during an unknown procedure there was intraoperative blade fracture.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/12/2025.D4 batch #: y7046l.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 no apparent damage and the blade not broken off as reported.During functional testing on gen11, an alert screen was displayed.The device will stop activating when the blade becomes damaged.The device was disassembled to inspect the blade and a crack was located at an area inside the tube proximal to the tissue pad.This is consistent with a side load being applied to the blade while active with the jaw closed.The blade broke off during functional testing.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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 "remove instrument from patient" or ¿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.No conclusion could be reached as to how the blade crack issue occurred.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 batch y7046l, and no non-conformances were identified.

• 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: 23682325
• Report Number: 3005075853-2025-09054
• Device Sequence Number: 9761187
• 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): 12/01/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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