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

Model Number	HAR745
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon tried using the harmonic 700 series shears, but the device was not functional and would not seal.A second harmonic 700 series shears was opened and was functional.Minimal delay, no identified harm.

• Brand Name: HARMONIC
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 24321481
• Report Number: 24321481
• Device Sequence Number: 13117543
• Product Code: LFL
• UDI-Device Identifier: 10705036035787
• UDI-Public: (01)10705036035787(17)300531(10)Z70270
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025
• Report Date (Section F): 12/23/2025

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
• Device Model Number: HAR745
• Device Catalogue Number: HAR745
• Device Lot Number: Z70270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Date Report Sent to FDA: 12/23/2025