MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; LARGE SUTURE CUT NEEDLE DRIVER

Model Number	471296-10
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer experienced an issue with an intuitive product.The customer reported event has no report of patient injury.Isi followed up with the initial reporter to obtain additional information; however, no further details are available regarding the reported event.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The large suturecut needle driver instrument was analyzed and found to have a frayed grip cable at the yaw pulley.Some wires were broken, but the cable itself was not fully broken.There was no discoloration, corrosion, or contamination observed on the cable that would occur from improper flushing or rinsing during reprocessing.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.

• Brand Name: EndoWrist
• Common Device Name: LARGE SUTURE CUT 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: 50203119
• Report Number: 2955842-2026-35200
• Device Sequence Number: 10274489
• Product Code: NAY
• UDI-Device Identifier: 00886874121504
• UDI-Public: (01)00886874121504(11)251023(10)K10251023(91)0003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 471296-10
• Device Catalogue Number: 471296
• Device Lot Number: K10251023 0224
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories
• Patient Sex: Unknown