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

Catalog Number	HARHPBL
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the hand piece blue has eroded.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/25/2026.D4 batch #: y7004u.Additional information was obtained: they only had one blue handpiece that was corroded at the end of the metal handle.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 no apparent damage.The device was connected to a generator and evaluated with a test instrument, and was found to be functional.No communication issues were observed at any time during the testing.The handpiece was disassembled to verify the condition of the internal components, and the presence of moisture was confirmed.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 y7004u, and no non-conformances were identified.Although no definitive root cause could be drawn, it is possible that the ingress of moisture affected handpiece functionality.No patient involvement or adverse outcomes were reported in the investigation.

• Brand Name: HARMONIC BLUE HAND PIECE
• 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: 24443500
• Report Number: 3005075853-2026-01602
• Device Sequence Number: 10254495
• Product Code: LFL
• UDI-Device Identifier: 20705036023446
• UDI-Public: (01)20705036023446
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K063192
• 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): 02/25/2026

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: HARHPBL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown