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

Model Number	430006-62
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer experienced an issue with a single port (sp) needle driver instrument.The customer reported event has no report of patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The single port (sp) needle driver instrument was analyzed and found to have a broken idler roll gear, and a fragment of the gear was located inside the housing after disassembly.Manual articulation testing showed that the main tube rotated; however, the hard stop was not felt because the broken gear prevented proper articulation.Functional testing on an in-house system confirmed unintuitive motion.The main tube did not rotate when commanded by the master tool manipulator (mtm) on the surgeon side cart (ssc).When the wrist and joggle joint were bent and roll commands were applied, the distal end moved in a circular path rather than remaining in a fixed position while rolling as expected.In certain orientations, the distal tip also moved opposite to the commanded direction.This behavior was consistently observed in 3 of 3 installations, indicating misalignment of the coordinate frames during the engagement sequence.The unintuitive motion was attributed to the broken idler roll gear.The complaint regarding an issue with the instrument was confirmed by failure analysis.The probable root cause of the broken idler roll gear is attributed to improper reprocessing.

• 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: 50852389
• Report Number: 2955842-2026-39614
• Device Sequence Number: 18516017
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(11)241121(10)K10241121
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: K10241121 0012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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