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	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the harmonic ace instrument was damaged and became unusable.Troubleshooting was performed by replacing the instrument to the backup and this resolved the issue.Following this, the user continued the procedure with no further issue reported.No fragment fell into the patient.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the harmonic ace involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.The harmonic insert was found to have a broken blade.The blade broke at roughly.087¿ from the base.Broken piece was returned.Cracked or broken blades are triggered by any inadvertent contact with staples, clips, or other instruments while the device is activated.In addition, scratches on the blade tip may also lead to premature blade failure.Blade damage may be detected by the generator with a solid tone or an error.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).

• 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: 24450223
• Report Number: 2955842-2026-10737
• Device Sequence Number: 15989563
• Product Code: NAY
• UDI-Device Identifier: 10886874111083
• UDI-Public: (01)10886874111083(10)M90200103
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: M90200103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• 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