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

Model Number	430200-02
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 6mm needle driver instrument was analyzed and found to have a dislodged cable crimp.The crimp is located approximately 21.60 mm from the distal tip.The broken cable that was dislodged from the crimp is found approximately 40.25 mm from the distal tip.Due to the dislodged crimp, the instrument failed manual articulation at the yaw input.The instrument failed imprecise motion due to the dislodged cable crimp.Additional observation related to the customer complaint: the instrument was found to have imprecise motion failure.The instrument was installed on an in-house system and driven.Instrument exhibited imprecise motion in the yaw direction.The grip tips moved in the direction commanded, however a lag or delay in the motion was observed due to the dislodged cable crimp.The complaint was confirmed by failure analysis.The probable root cause is attributed to the instrument experiencing more load than anticipated.The cable crimp can become dislodged due to back-driving of wrist and joggle joints with the insertion axis.Applying excessive force on the instrument shaft and/or tip during handling, insertion, usage (overloading), or removal can also cause the crimp to dislodge.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 6mm needle driver instrument was not articulating properly.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred while the surgeon was operating inside the surgeon console¿s high resolution stereo viewer and attempting to manipulate instruments.Although the movement scaled appropriately and the timing was correct, the instrument did not move in the intended direction; the surgeon tried to move the wrist left, but the instrument moved circularly to the right.This problem was persistent throughout the procedure and was resolved by replacing the instrument with a new needle driver.There was no shakiness, friction, or patient injury observed.Photographic images or video recordings of the event are available for review, and the issue was noted within the first 45 minutes of the robotic start.

• 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: 24576103
• Report Number: 2955842-2026-15759
• Device Sequence Number: 9157842
• Product Code: NAY
• UDI-Device Identifier: 00886874123478
• UDI-Public: (01)00886874123478(10)H02162602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: 430200-02
• Device Catalogue Number: 430200
• Device Lot Number: H02162602 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2026
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White