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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/4/2025.B3: event year only reported: 2025.D4 batch #: unknown.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 a hemicolectomy the scissors do not turn off after pressing the button; they continue to run.Procedure finished with same like device.No patient harm nor significant delay reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/15/2026.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/13/2026.D4 batch #: a97x38.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.The device was connected to a test handpiece and tested on a gen11.The device did activate when each of the max and min hand activation buttons were depressed, but no continuous activation occurred at any time during functional testing.The device was disassembled to verify the condition of the internal components and no anomalies were found that could have caused a continuous activation.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the device batch a97x38, 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: 23720280
• Report Number: 3005075853-2025-09201
• Device Sequence Number: 8745008
• Product Code: LFL
• UDI-Device Identifier: 10705036014430
• UDI-Public: (01)10705036014430(17)300331(10)A97X38
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/04/2025

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: A97X38
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 02/12/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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: HANDPIECE AND GENERATOR.
• Patient Sex: Unknown