MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist SP; CADIERE FORCEPS

Model Number	430009-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the cadiere forceps.Failure analysis confirmed and replicated the customer complaint.Failure analysis found the primary finding of the instrument roll gear broken to be related to the customer reported complaint.The cadiere forceps instrument was found to have a broken idler roll gear.The cadiere forceps housing was removed, and a piece of broken roll gear was found inside the housing.During a manual articulation of the inputs, the hard stop was not felt.It was noted that the broken gear prevented the main tube from articulating.The instrument failed to move intuitively during functional testing on the in-house system due to the broken roll gear.The instrument exhibited unintuitive motion due to the broken idler gear.The instrument was installed on an in-house system and driven.When placed on the in-house system, it was observed that the main tube did not rotate when commanded with the manual tool manipulator (mtm) on the surgeon side cart (ssc).With the instrument's wrist and joggle joint bent and commanding the instrument to roll, the instrument distal end would move in a circle, which appeared to be an unintuitive motion, as the circular motion was unexpected; the expected motion was for the distal end of the instrument to stay in a consistent location and only spin and roll.Additionally, in certain orientations over the ran of the roll direction, the instrument's distal tip moved opposite to what was commanded by the mtm.This behavior was observed in the roll direction and presented on all three installs, indicating a misalignment of the coordinate frames during the engagement sequence.The probable root cause is attributed to excessive user-applied mechanical loading beyond normal operating conditions, resulting in a fractured idler roll gear within the roll drive train.

• Brand Name: EndoWrist SP
• Common Device Name: CADIERE FORCEPS
• 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 ; +1(408)523-2100
• MDR Report Key: 50063618
• Report Number: 2955842-2026-33769
• Device Sequence Number: 10745982
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(10)K10250320
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 430009-62
• Device Catalogue Number: 430009
• Device Lot Number: K10250320 0022
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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
• Patient Sex: Unknown