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

Catalog Number	HAR9F
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 6/5/2026 b3: unknown; captured as awareness date d4 batch #: unknown d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information was requested and the following was obtained: what was the exact surgical procedure? unk what is the user¿s experience with the device? unk what generator power level was being used in the original procedure? unk were there any issues with the device during the original procedure? no what named vessels was the device used on in the original procedure? unk what was the approximate width of the vessel(s)? unk how was the bleeding identified? unk when was the bleeding identified? bleeding occurred after the original procedure.What was the source of bleeding? unk what was done to address the bleeding during the re-op? please provide more detail on the assessment of the cause of this event to be related to the user and not device.=>the attending physician commented that there were no issues with the device and that it is recognized as a user-related problem.What is the patient¿s current status? the patient is progressing without any problems since re-operation.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.
Event or Problem Description
It was reported by the sales rep that, after an unknown ent (eyes, nose, and throat) surgery, postoperative bleeding occurred, and upon performing reoperation, treatment was performed.The patient has recovered without any problems since the reoperation.The surgeon believes the cause of this event is not a problem with the instrument, but rather the issue was identified as being on the user's end.No further information is available.

• Brand Name: HARMONIC FOCUS
• 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: 25415673
• Report Number: 3005075853-2026-04309
• Device Sequence Number: 5840456
• Product Code: LFL
• UDI-Device Identifier: 10705036014669
• UDI-Public: 10705036014669
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133314
• 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): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HAR9F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown