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

Catalog Number	HAR17F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, during the intervention, the jaw broke.The fragment was retrieved.The issue led to a surgical delay.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/21/2024.B3: event year only reported: 2024.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: did the active titanium blade break off? did the white tissue pad break off? is the white tissue pad completely missing from the clamp arm of the device? did the patient experience any adverse consequences due to this issue? 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/15/2026.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: HARMONIC
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20746066
• Report Number: 3005075853-2024-08881
• Device Sequence Number: 8755570
• Product Code: LFL
• UDI-Device Identifier: 10705036014737
• UDI-Public: (01)10705036014737(17)281130(10)411C26
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2024

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: HAR17F
• Device Lot Number: 411C26
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 04/30/2026; 04/30/2026
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 05/15/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE AND GENERATOR
• Patient Sex: Unknown