MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; HARMONIC ACE

Model Number	400272-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.The harmonic ace instrument was analyzed and found to have a broken curved blade.Broken piece, approximately 0.27"" x 0.10"" was returned.No material appeared to be missing as the broken assembly was pieced back together.The complaint regarding broken jaw was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The probable root cause of the broken blade is attributed to use conditions.Broken blades result from blade scratches and damage caused by contact with other instruments or other hard/metal objects (e.G., staples, clips, etc.) during use while the instrument is activated.Blade fractures propagate from initial contact sites due to the ultrasonic vibration of the harmonic ace blade, leading to eventual/premature failure (e.G., scratches and damage result in cracks, which then result in broken blades).
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the harmonic ace had broken tip.There was no allegation of fragment fallen inside the patient.The customer used a backup instrument of the same kind to continue.The procedure was completing as planned with no reported injury.

• Brand Name: NONE
• Common Device Name: HARMONIC ACE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 24450292
• Report Number: 2955842-2026-10759
• Device Sequence Number: 13254034
• Product Code: NAY
• UDI-Device Identifier: 10886874111083
• UDI-Public: (01)10886874111083(10)L90211111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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 Model Number: 400272-03
• Device Catalogue Number: 400272
• Device Lot Number: L90211111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown