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

Catalog Number	HARHPGR
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an urological procedure the harhpgr has been connected with gen11 a message appeared: "replaced hand piece." 89 usages remain in the hand piece replaced the handpiece.The procedure was delayed 10 minutes but completed successfully.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/23/2025.D4 batch #: y7043u.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 handpiece was received with nose cone slightly separate from the mid housing.Due the condition of the device returned we were unable to perform the functional test.The handpiece was disassembled to verify the condition of the internal components, and no anomalies were found.No conclusion can be made as to why the nose cone got separated.A manufacturing record evaluation was performed for the finished device batch y7043u, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: HARMONIC GREY 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: 22579848
• Report Number: 3005075853-2025-05839
• Device Sequence Number: 20641140
• Product Code: LFL
• UDI-Device Identifier: 20705036023422
• UDI-Public: (01)20705036023422
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: HARHPGR
• Device Lot Number: Y7043U124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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