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

Model Number	430100-02
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 6mm monopolar curved scissors was analyzed, and the findings did not replicate or confirm the customer reported event.The unit was analyzed and prior to inhouse testing, an inhouse mcs tip was placed on the instrument.The instrument was tested twice and passed the recognition and engagement tests with no issues.The instrument moved intuitively with full range of motion in all directions.The tips opened and close properly.The instrument was fully functional.Visual inspection was performed and found no external damage to the housing or tip.The housing was removed for inspection and found no internal damages.No errors were found during log review.The inputs disks were manually articulated with no issues.The grip knob was able to rotate, allowing the grips to open/close without any issues.The instrument tube adapted was inspected and found no damage.No product issue was found.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the 6mm monopolar curved scissors instrument was moving in the opposite direction than intended.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred while the surgeon was seated at the surgeon console with their head inside the high resolution stereo viewer and attempting to manipulate instruments.When trying to move the instrument left, it moved right, and vice versa; the instrument's movement was opposite to what was intended.It is unclear whether the instrument movement was proportional to the surgeon¿s hand movements or if there was any lag, but no complaints of delay or shakiness were reported.The issue happened persistently: after reseating the instrument, the problem recurred, and the instrument had to be replaced with a new one.There were no patient injuries, instrument or system collisions, or unusual findings during pre-use inspection.

• 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: 25209032
• Report Number: 2955842-2026-25171
• Device Sequence Number: 18387840
• Product Code: NAY
• UDI-Device Identifier: 00886874123454
• UDI-Public: (01)00886874123454(10)H02212602
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: 430100-02
• Device Catalogue Number: 430100
• Device Lot Number: H02212602 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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
• Patient Sex: Unknown