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

Catalog Number	HPBLUE
Medical Device Problem Code	Excessive Heating (4030)
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: 5/6/2025.B3: event year only reported: 2025.D4 batch #: t93x4l.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 received with the 6-32 stud slightly damaged.The device could be assembled and tested and was functional.It is possible that the stud got damaged as a result of dropping it.The handpiece was disassembled to verify the condition of the internal components,.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.However, no definitive root cause could be drawn.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event.It is probable that the this damaged affect the handpiece functionality.A manufacturing record evaluation was performed for the finished device batch t93x4l, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure the handpiece overheats abnormally when used.It was seen with the urology operating room.The forceps have 33 uses remaining.There were no patient consequences.

• 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: 21971342
• Report Number: 3005075853-2025-03431
• Device Sequence Number: 20863862
• Product Code: LFL
• UDI-Device Identifier: 20705036002151
• UDI-Public: (01)20705036002151
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/06/2025

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: HPBLUE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2019
• 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