MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CURVED SCISSORS

Model Number	430100-02
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip detached from the mcs instrument.While removing the mcs tip, the customer noticed that the instrument's joint was broken and some pieces had fallen off.The customer immediately removed the fragments during the same surgical procedure which was completed robotically.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the mcs instrument was inspected prior to use and showed no damage or abnormalities.The fragment(s) fell off during removal of the instrument removal.There was no collision with other instruments and no resistance was felt during removal of the instrument.No damage was observed to the cannula.The fragment was retrieved during the same procedure, with confirmation that all pieces were accounted for by matching them with the instrument.No additional surgical procedures or post-operative tests (such as x-rays or ultrasounds) were required, and the procedure was completed robotically without any injury to the patient or post-surgical complications.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) instrument to perform failure analysis.The instrument was analyzed and found to have a broken instrument tube adapter.The broken piece was not returned and measured approximately 1.70 mm x 2.80 mm in size.An in-house mcs tip accessory was successfully installed despite the damage.Manual tip articulation was performed and passed.The grip did open and close properly when the grip knob was manually rotated.The instrument was placed on the in-house system testing and passed energy delivery.The instrument moved intuitively with full range of motion in all directions.A review of an image provided by the customer was performed.The image exhibits an sp mcs instrument with a broken tube adapter component.This is the component that accepts the mcs tip accessory.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CURVED SCISSORS
• 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: 24611739
• Report Number: 2955842-2026-15971
• Device Sequence Number: 13307382
• Product Code: NAY
• UDI-Device Identifier: 00886874123454
• UDI-Public: (01)00886874123454(11)250904(10)K10250904
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K241814
• 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
• Report Date (Section B): 03/16/2026

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: 430100-02
• Device Catalogue Number: 430100
• Device Lot Number: K10250904 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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