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

Catalog Number	HAR23
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 7/30/2025 d4 batch #: u95g7c.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 black coating of the blade damaged.The device was connected to a test handpiece and tested on a gen11.The device did activate during functional testing.The device was analyzed, and it was determined that it was possibly used in more than one procedure, based on generator data.The device is intended and labeled for single patient use.If the device is connected to multiple generators, an alert screen will be displayed indicating ¿adaptive tissue technology features are not available in this device¿.The device was disassembled to verify the condition of the internal components and no anomalies were found.Occasionally, damage to the blade coating occurs when the blade is exposed to metal contact and/or high heat/prolonged activation without tissue present in the distal section of the jaws and the jaws closed.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 damaged blade can result in a broken blade.Due to the multiple generator usage, which is evidence of possible reuse, we are unable to determine how this condition impacted the performance of the device and, therefore, cannot conclude the root cause.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 u95g7c, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure the "no instrument uses remaining" screen was displayed by the generator.Changed to another device to complete surgery.There was no patient consequence reported.No additional information can be provided.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 22664436
• Report Number: 3005075853-2025-06009
• Device Sequence Number: 3702358
• Product Code: LFL
• UDI-Device Identifier: 10705036014430
• UDI-Public: (01)10705036014430(17)250930(10)U95G7C
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 07/30/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: HAR23
• Device Lot Number: U95G7C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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 AND HANDPIECE
• Patient Sex: Unknown