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

Catalog Number	HARHPGR
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/12/2025.D4 batch #: y7041r.Investigation summary: the handpiece was received disassembled and the ¿transducer assembly¿ attached to a ace36e device.The nose cone was cracked.The "transducer assembly" was forcibly removed from the disposable.No functional testing could be done due to the condition of the returned device.Non-destructive testing was performed as per customer request to get the handpiece device back and not disassembled.It is possible that the cracked nose cone caused the reported assembly/disassembly issues.Analysis was unable to determine the exact root cause that lead to crack in the hand piece nosecone.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported event.It is possible that the ingress of moisture affected handpiece functionality.A manufacturing record evaluation was performed for the finished device batch y7041r, and no non-conformances were identified.
Event or Problem Description
It was reported that, during an unknown laparoscopic surgery, the handpiece could not be removed after the operation.The blade tip was not broken off and no pieces fell into the patient.The same device was used as is to complete the case because this event was found after use.There were no adverse consequences to the patient.No further information is available.

• 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: 23789826
• Report Number: 3005075853-2025-09431
• Device Sequence Number: 10470538
• Product Code: LFL
• UDI-Device Identifier: 20705036023422
• UDI-Public: (01)20705036023422
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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