MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HARHPGR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/29/2026.D4 batch #: y7053n043.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 revealed that the device was received with the coating material of the housing was flaking off.Based on prior investigations, the loose particles on the surface are likely aluminum oxide from the base material.It was connected to a generator, evaluated with a test instrument, and was found to be functional.Additionally, photos was provided and they showed the condition of the device returned.The instrument was disassembled to inspect internal components and the moisture indicator was positive.The handpiece has a number of seals to prevent fluids from entering the housing."positive moisture indicator¿ describes a condition where water enters the handpiece cavity during the steam sterilization process.The primary path of ingress is the distal seal, this may be caused by a reduction of the compressive force on the distal seal.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.However, no definitive root cause could be drawn.
Event or Problem Description
It was reported that during an unknown procedure the device has a breakdown.No more information available.

• Brand Name: HARMONIC
• 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: 25033826
• Report Number: 3005075853-2026-03238
• Device Sequence Number: 15713205
• Product Code: LFL
• UDI-Device Identifier: 20705036023422
• UDI-Public: (01)20705036023422
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K002906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: HARHPGR
• Device Lot Number: Y7053N043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown