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

Catalog Number	HAR9F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the device was connected to the gen11 and directly the gen indicated the tip/jaw was broken.The needed to change to a new device and then it worked.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/16/2026.B3: event month is unknown.D4 batch #: unknown.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/7/2026.D4 batch #: z7023d.Corrected data: d4 udi # and expiration date, h4.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 returned with no apparent damage.Functional testing was performed with the generator, and the device worked as intended; no alert screens were displayed at any time during testing.The har9f device is equipped with an eeprom that collects error codes associated with generator alert screens.During the analysis of the data collected in the eeprom while using the device, it was noted that the device triggered the "tighten assembly" alert screen.This alert occurs when the instrument is not properly assembled with the handpiece.To ensure proper assembly, the torque wrench supplied with the device should be used to tighten the blade onto the handpiece.Turn the torque wrench clockwise while holding the handpiece, and continue until it clicks twice, indicating that sufficient torque has been applied to secure the blade.For further details, please refer to the instruction for use.There were no " blade tip broke off" issues observed at any time during analysis.Due to the event description reported the investigation was confirmed.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 z7023d, and no non-conformances were identified.

• Brand Name: HARMONIC FOCUS
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 24605185
• Report Number: 3005075853-2026-02021
• Device Sequence Number: 18448963
• Product Code: LFL
• UDI-Device Identifier: 10705036014669
• UDI-Public: (01)10705036014669(17)300430(10)615D87
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K132612
• 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,Followup
• Report Date (Section B): 03/16/2026

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: HAR9F
• Device Lot Number: 615D87
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown