MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist SP; NEEDLE DRIVER

Model Number	430006-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the single port (sp) needle driver instrument was not responding to the commands.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The needle driver instrument was analyzed and found to have a broken idler roll gear.Upon removal of the instrument housing, a fragment of the broken roll gear was discovered inside the housing.During manual articulation of the inputs, the expected hard stop was not felt.The broken gear was found to prevent the main tube from articulating, and the instrument failed to move intuitively during functional testing on the in-house system.Additionally, the instrument exhibited unintuitive motion during in-house system testing, consistent with the reported complaint.When installed and driven, the main tube did not rotate as commanded by the mtm (master tool manipulator) or ssc (surgeon side console).With the wrist and joggle joint bent and a roll command issued, the distal end moved in a circular pattern rather than spinning or rolling in place as expected.Additionally, in certain orientations within the roll direction range, the distal tip moved opposite to the commanded direction.This behavior was observed across all three installs, suggesting a misalignment of the coordinate frames during the engagement sequence.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.

• Brand Name: EndoWrist SP
• Common Device Name: NEEDLE DRIVER
• 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: 50928531
• Report Number: 2955842-2026-40307
• Device Sequence Number: 10749644
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 430006-62
• Device Catalogue Number: 430006
• Device Lot Number: U10241023 0006
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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