MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FORCE FEEDBACK; FORCE FEEDBACK MEGA SUTURECUT NEEDLE DRIVER

Model Number	476309-17
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
It was reported that out of box, the driver of the force feedback mega suturecut needle driver came apart in the packaging.There was no report of patient involvement.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback mega suturecut needle driver was analyzed and the reported issue was confirmed.Failure analysis found the primary failure of dislodged main tube to be related to the customer reported complaint.The main tube assembly was found to be dislodged from its normal position.The root cause of this failure is attributed to the user caused by damage during use or reprocessing.Damage can result from mechanical impact, such as an accidental drop of the instrument, or excessive force applied during handling.Further investigation confirmed additional observations.As a result of the broken main tube holder, the instrument was found to have the main tube holder broken.Pieces of the main tube holder measuring approximately 2.11mm x 1.40mm and 2.68mm x 1.26mm was not returned with the instrument.Common cause of this failure is attributed to the user.The instrument was found to have a bent main tube.The bending damage is located at the proximal end of the main tube.Components adjacent to this bent main tube do not show damage.Common causes of the failure mode bent instrument main tube are attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments.Applying excessive force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal can also cause bending.The instrument was found to have a detached fragment.The detached fragment was the result of the dislodged main tube.The missing pieces measuring 8.72mm x 4.73mm and 8.55mm x 4.95mm were returned with the instrument.The root cause of this failure is attributed to user.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK MEGA SUTURECUT 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: 24450211
• Report Number: 2955842-2026-09959
• Device Sequence Number: 9336614
• Product Code: NAY
• UDI-Device Identifier: 00886874125601
• UDI-Public: (01)00886874125601(10)K10251016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243641
• 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,Followup
• Report Date (Section B): 03/06/2026

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: 476309-17
• Device Catalogue Number: 476309
• Device Lot Number: K10251016 0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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