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

Model Number	431100-02
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument involved in this complaint has been received and tested by failure analysis.The single-port (sp) monopolar curved scissors (mcs) instrument was analyzed and found to have a cable crimp dislodged from the distal joggle joint.The cable with the dislodged crimp appeared frayed and detached.The dislodged crimp likely caused the broken joggle constraint cable.During articulation of the input disks, the yaw had some friction.Visual inspection was performed and found no damage to the housing.Additional findings related to the customer reported complaint: the instrument was found to have imprecise movement.An mcs tip was installed prior to in-house testing.The sp mcs instrument was installed on an in-house system and driven.The instrument passed the recognition and engagement tests.Although the instrument moved intuitively with full range of motion in almost all directions, while manipulating the mtm (master tool manipulator) the instrument failed yaw.The instrument struggled to straighten when putting the tip in yaw position.Instrument exhibited imprecise motion likely caused by the missing crimp.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, while excising the myoma protruding from the front of the uterus and dissecting the tissue, it appeared on the surgical screen that the jaw of the monopolar curved scissors (mcs) instrument was not closing completely.The surgeon attempted to open and close the jaw several times and, suspecting it was not functioning properly, requested an instrument check.Upon removing the sheath and inspecting the wire, it was discovered that the wire near the tip was broken.While checking the instrument's operation by opening and closing the release dial, it was confirmed that the wire was breaking little by little when the jaw was opened and closed.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CURVED SCISSORS ER
• 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: 24434734
• Report Number: 2955842-2026-08580
• Device Sequence Number: 18703180
• Product Code: NAY
• UDI-Device Identifier: 00886874124048
• UDI-Public: (01)00886874124048(11)250514(10)K10250514
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: 431100-02
• Device Catalogue Number: 431100
• Device Lot Number: K10250514 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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
• Patient Sex: Female