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	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the single port needle driver instrument involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted malignant hysterectomy surgical procedure, single-port (sp) needle driver (nd) on patient side manipulator (psm) 3 moved in a opposite direction with the surgeon¿s control.Intuitive surgical, inc.(isi) technical support engineer (tse) had the customer reseat the nd instrument and sterile adapter (sa), but the issue was not resolved.The tse had the customer replace the nd instrument to resolve the issue.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred when the surgeon¿s head was inside the high-resolution stereo viewer (hrsv) and when the surgeon was attempting to manipulate instruments from the surgeon side console (ssc).The timing of instrument movement was appropriate.There was no shakiness or friction.There was no instrument-to-instrument or system arm-to-arm interference.There were no external collisions.The issue was persistent after removing of the instrument and power cycling the system.The issue was resolved after replacing the instrument.There was no patient injury due to the issue.The issue occurred after approximately one hour and twenty minutes after the start of the procedure.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The needle driver instrument was installed on an in-house system and driven an exhibited unintuitive motion.The motion exhibited by the instrument was precise, and proportional to what was commanded by the master tool manipulators (mtm); however, the grip tips moved in the opposite direction.This behavior was observed in the roll direction, indicating a misalignment of the coordinate frames during the engagement sequence.During inspection it was found that the instrument had a broken roll idler gear.As a result, the input shaft became nonfunctional causing the instrument to exhibit non-intuitive motion.The broken piece of the roll idler gear measured approximately 4.60mm x 12.65mm and was captured inside of the housing.The complaint was confirmed by failure analysis.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.
Event or Problem Description
Refer to h11 for follow-up information.

• 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 ; 4085232100
• MDR Report Key: 22935521
• Report Number: 2955842-2025-35633
• Device Sequence Number: 21298423
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(11)240516(10)K10240516(91)0001
• 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): 08/06/2025

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: K10240516 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: Female