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

Model Number	431100-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a da vinci-assisted surgical procedure, the tip of the monopolar curved scissors instrument could not be attached.There was no reported injury.
Additional Manufacturer Narrative
The monopolar curved scissors has been returned and evaluated by the failure analysis team.The reported event with the instrument could not be replicated nor confirmed.The in-house mcs tip was installed properly despite the damage to the tube adapter.The grip was manually rotated, and the in-house mcs tip opened and closed properly.The inputs were manually articulated and passed.The housing was removed and found to be undamaged.The instrument was tested on an in-house system and passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grip tips opened and closed properly.The instrument passed energy delivery testing in various grip orientations.The instrument also passed the electrical continuity test.The instrument was fully functional.Additionally, the instrument was found to have a broken instrument tube adapter.This component is located at the distal end of the instrument and serves as the interface between the instrument and the user-installed tip accessory.The broken piece was not returned and measures approximately 1.43 mm x 2.07 mm in size.

• 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: 25224267
• Report Number: 2955842-2026-25706
• Device Sequence Number: 9997753
• Product Code: NAY
• UDI-Device Identifier: 00886874124048
• UDI-Public: (01)00886874124048(10)K10251211
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: K10251211 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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: Unknown