MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; MONOPOLAR CURVED SCISSORS (MCS) TIP

Model Number	430035-13
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The single port (sp) monopolar curved scissors (mcs) tip has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the single port (sp) monopolar curved scissors (mcs) tip fell off the instrument many times and fell into the patient.During the surgical task of dissection, a fragment fell into the patient.The fragment was retrieved by the assistant and confirmed to be retrieved by checking that the tip was complete.No additional procedure was performed to retrieve the fragment nor were post operative imaging tests done due to the fallen fragment.The procedure was completed robotically with a back-up mcs tip.There was no injury to the patient, and the patient has not returned to the hospital due to any post-surgical complications related to retaining a foreign object.The mcs tip is available to be returned to isi.No photographic images of the device(s) or video recording of the procedure were available for intuitive surgical, inc.(isi) review.
Additional Manufacturer Narrative
Updated fields: d9, h2, h3, h6, and h11.Device evaluation: intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) tip accessory to perform failure analysis.The mcs tip was analyzed and the retaining cover of the mcs tip appeared to be completely dislodged from the blades.The blades did not appear damaged.No missing material was found.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Updated fields: h2 and h11.Additional information: on 10-feb-2026, intuitive surgical, inc.(isi) received monopolar curved scissors (mcs) instrument (lot #k10250319-0023) to perform failure analysis.An in-house mcs tip was installed onto the instrument's tube adapter with no issues despite the fact that the tube adapter was found to be broken.The instrument was then tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The blades opened and closed properly.The mcs tip accessory remained installed onto the instrument's tube adapter through the entirety of the test.The tube adapter component is located at the distal end of the instrument and serves as the interface between the instrument and the user installed tip accessory.A broken piece from the tube adapter, measuring approximately 1.30mm x 1.77mm in size, was found to be detached and not returned with the instrument.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: MONOPOLAR CURVED SCISSORS (MCS) TIP
• 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: 23692910
• Report Number: 2955842-2025-47044
• Device Sequence Number: 18422926
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(17)270228(10)K10250213
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430035-13
• Device Catalogue Number: 430035
• Device Lot Number: K10250213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 02/10/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown