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

Catalog Number	HAR745
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/30/2026 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.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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 that during the conversion of sleeve to bypass procedure, the active blade of the harmonic device broke, and a piece or remnant fell off into the patient's body, but it was retrieved.No x-ray was done but they were able to visually see the remnant and retrieved it.The patient is doing fine now.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/23/2026 corrected data: d4 udi # a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: HARMONIC
• 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 24731157
• Report Number: 3005075853-2026-02365
• Device Sequence Number: 9287026
• Product Code: LFL
• UDI-Device Identifier: 10705036035787
• UDI-Public: (01)10705036035787(17)300131(10)Z7006L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2026

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: HAR745
• Device Lot Number: Z7006L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/22/2026; 04/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/23/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (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