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

Catalog Number	HARHPGR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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
The device was received with no event details.Attempts were made to obtain details and no information was provided.No patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/10/2026.B3: event year only reported: 2026.D4 batch#: y7043u.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device, but no functional testing could be performed due to the condition of the device.Visual analysis of the returned sample revealed that the device was received with the nose cone slightly separated and the mount was noted to be loose.No functional testing could be performed due to the condition of the device returned.The instrument was disassembled to inspect internal components; the moisture indicator was positive, the acoustic isolator was torn, and the transducer assembly was not held in place due to the nose cone condition, resulting in twisting of the handpiece transducer assembly until the internal wires got disconnected.Due to the nose cone condition, moisture entered the hand piece mid housing, and it is possible that the ingress of moisture affected handpiece functionality.Although the analysis was unable to determine the exact root cause that led to the hand piece nose cone damaged.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: y7043u, and no non-conformance's were identified.

• 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: 24304140
• Report Number: 3005075853-2026-01196
• Device Sequence Number: 18561627
• Product Code: LFL
• UDI-Device Identifier: 20705036023422
• UDI-Public: (01)20705036023422
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 02/10/2026

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: HARHPGR
• Device Lot Number: Y7043U134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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