MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. Harmonic Focus; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR9F
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thyroidectomy procedure, during usage, surgeon had complained that the device was not coagulating tissue well and ineffective in its function.Surgeon then decided to use another device to complete the surgery.Upon surgery completion, the patient was extubated.Upon extubating the patient, there was a bleeding incident originating from the surgical site.Decision was made to re-open the surgical site and investigate.Surgeon noticed that the bleeding was originated from the strep muscle and made a deduction that the bleeding was due to the har9f ineffectively sealing the strep muscle during the initial stage of surgery.Bleeding was controlled and patient was managed.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/6/2026.D4 batch #: unknown.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what is meant by and what exactly was experienced when it was said ¿the har9f was not coagulating tissue well and ineffective in its function? did the surgeon hear proper tones during device usage? were there any error messages during the original procedure? what generator settings were used in the procedure? what is the surgeon¿s experience level with the device? did they check the hemostasis effect prior to closing the patient? what device was used to complete the surgery, another har9f or something else? was it used on the tissue where the bleeding originated? how was the bleeding controlled when the patient was re-opened? what is the patient¿s current status? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 Focus
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50165115
• Report Number: 3005075853-2026-06401
• Device Sequence Number: 10032846
• Product Code: LFL
• UDI-Device Identifier: 10705036014669
• UDI-Public: (01)10705036014669(17)300630(10)669D54
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2026

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
• Device Lot Number: 669D54
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: Not provided; 08/20/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/20/2026; 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown