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

Catalog Number	HPBLUE
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the blue hand piece is broken.It requires to make the test again and again.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/16/2026.D4 batch #: x94h1y.Additional information was requested and the following was obtained: they said that the test did not go through.The generator asked to do the testing over and over again.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, evaluated with a test instrument, and was found to be functional.The handpiece was disassembled to verify the condition of the internal components, and the moisture indicator was positive.It is possible that the ingress of moisture affected handpiece functionality.No unexpected ready to pre run issues were observed at any time during the testing.Additionally, a photo was provided and they showed the device returned.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, with the primary path of ingress being the distal seal, which may be caused by a reduction of the compressive force on the distal seal.However, no definitive root cause could be drawn.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 x94h1y, and no non-conformances were identified.

• 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: 24605726
• Report Number: 3005075853-2026-02024
• Device Sequence Number: 10338082
• Product Code: LFL
• UDI-Device Identifier: 20705036002151
• UDI-Public: (01)20705036002151
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: HPBLUE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2022
• 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