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

Model Number	470194-09
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the mega needle driver instrument to perform failure analysis (fa).Fa was not able to confirm nor reproduce the customer reported complaint.Visual inspection did not reveal any damage.The instrument grips were manually manipulated, and the grip tips opened and closed properly.The instrument was tested on an in house system and passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.Functional testing confirmed that the grip tips were able to grasp and hold as intended.The instrument was fully functional.No product issue was found.
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the mega needle driver instrument was going the opposite way.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: no patient injury or visible damage to the instrument, including jaws, tips, or cables, was reported.The issue was resolved by replacing the instrument.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA 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: 25107432
• Report Number: 2955842-2026-24045
• Device Sequence Number: 18464816
• Product Code: NAY
• UDI-Device Identifier: 00886874112342
• UDI-Public: (01)00886874112342(11)250925(10)K11250925(91)0001
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 470194-09
• Device Catalogue Number: 470194
• Device Lot Number: K11250925 0116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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: Female