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

Catalog Number	HP054
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the start up of the unknown surgery, the harmonic 700 and handpiece hp054 could not connect to the gen11 generator.A message was displayed on the screen: "reactivate - two switch activations detected.Reactivate instrument to continue." the generator "froze" and it was not possible to proceed with any action.After a couple of tries, redoing the connection with the harmonic 700, we replaced the handpiece hp054 with another handpiece harhpgr.It then worked as normal.The procedure was delayed 15 minutes.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/26/2026.D4 batch #: g9l06g.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 the nose cone cracked.Due to the condition of the handpiece, no instrument could be attached to the handpiece for testing.Therefore, no functional testing could be performed.Due to the condition of the returned device, we have not been able to further investigate the reported issue.Additionally, photo was provided and they showed the alert screen displayed.The handpiece was disassembled to verify the condition of the internal components, and no anomalies were found.Analysis was unable to determine the exact root cause that led to crack in the hand piece nosecone.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 g9l06g, 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
• 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: 25279286
• Report Number: 3005075853-2026-03875
• Device Sequence Number: 9968205
• Product Code: LFL
• UDI-Device Identifier: 20705036002144
• UDI-Public: (01)20705036002144
• 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): 05/26/2026

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: HP054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2010
• 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