MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC 700 SHEARS 23CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR723
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rectocolectomy, robot converted to laparo the clamp does not work on the generator.Taking an ultracision of another brand to operate.Loss of chance for the patient because the surgeon had to operate with equipment of the wrong size for the patient.
Additional Manufacturer Narrative
(b)(4) date sent: 3/19/2025 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 was the original device and generator that was used? what problems occurred with the original device? what was the software version on the gen11? when converting from robotic, did the procedure become open or a laparoscopy? was the decision to switch from the robotic procedure due to the issues that occurred with the har723? what device and generator was used to complete the procedure? 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: 4/3/2025.Corrected data: b1, h1.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Additional information was requested and the following was obtained: what was the original device and generator that was used? unk.What problems occurred with the original device? no dection of the device.What was the software version on the gen11? maybe version 2016.When converting from robotic, did the procedure become open or a laparoscopy? open.Was the decision to switch from the robotic procedure due to the issues that occurred with the har723? no, but the material in 23 cm that did not work complicated the way open.What device and generator was used to complete the procedure? clamp/wire/knots.No devices.

• Brand Name: HARMONIC 700 SHEARS 23CM
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21642066
• Report Number: 3005075853-2025-02016
• Device Sequence Number: 15392791
• Product Code: LFL
• UDI-Device Identifier: 10705036035763
• UDI-Public: (01)10705036035763(17)290331(10)Y7014Z
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221790
• 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
• Report Date (Section B): 03/19/2025

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: HAR723
• Device Lot Number: Y7014Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown