MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC LAP 5MM SHEAR 23CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR23
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown surgery, there were several instances where the output lasted for about 1 to 2 seconds immediately after the device was stopped to use and the jaws were opened.The jaws were opened securely and the device was used with caution to avoid burns.The blade tip was not broken off and no pieces fell into the patient.Gen11 was used.The number of remaining uses of harhpgr was unknown.The same device was used as is to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/22/2025.B3: unknown; captured as awareness date.D4 batch #: unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/9/2026.D4 batch #: a97w4u.Corrected data: d4 udi #.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 blade tip damaged, however, the blade was not cracked.The device was connected to a test handpiece and tested on a gen11.The device did activate during functional testing.No continuous activation issues could be identified during testing.The device was disassembled to verify the condition of the internal components and no anomalies were found.If the device is activated across a clip, staple line, or other metal in the jaws, the blade 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 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 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 batch a97w4u, and no non-conformances were identified.

• Brand Name: HARMONIC LAP 5MM SHEAR 23CM
• 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: 23864287
• Report Number: 3005075853-2025-09713
• Device Sequence Number: 18643537
• Product Code: LFL
• UDI-Device Identifier: 10705036014430
• UDI-Public: (01)10705036014430(17)300330(10)A97W4U
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: HAR23
• Device Lot Number: A97W4U
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR AND HANDPIECE.
• Patient Sex: Unknown