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

Model Number	476309-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted liver resection surgical procedure, the force feedback mega suturecut needle driver was cracked at the tip.The procedure was completed as planned with no reported injury.The reported issue was identified while the instrument was being placed through the trocar during a liver resection procedure.It is unknown when the instrument damage occurred.The reporter informed that is it unknown whether or not the crack at the tip of the instrument resulted in a fragment, but there was no fragment reported by the staff.The procedure was completed as planned without any injury or harm to the patient.
Additional Manufacturer Narrative
An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
Failure analysis investigations replicated and confirmed the customer-reported complaint.The instrument was found to have a frayed grip cable at the grip hub.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.Further investigation confirmed additional observations.The instrument housing was removed for visual inspection, and it was found that the rfid retainer and identification board were dislodged from their normal position.The identification board and rfid retainer were found loosely inside the housing.A dislodged identification board can result in instrument recognition failures as it prevents the data from being accessed by the system during installation.The root cause of the dislodged rfid and resulting recognition failure is likely due to the rfid retainer component not being fully seated during the manufacturing process, which caused it to become dislodged during handling or transit.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The force feedback mega suturecut needle driver was analyzed by failure analysis.The instrument had 5 of 6 uses remaining.The root cause of the reported issue was related to user misuse.Visual inspection confirmed the user complaint that there was a crack in main tube overmolded extension, which can occur due to mishandling or scenarios where excessive force is applied to the instrument.Visual inspection of the instrument also showed that what was originally identified as a frayed grip cable was not actually frayed.
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: 22163986
• Report Number: 2955842-2025-24293
• Device Sequence Number: 18013418
• Product Code: NAY
• UDI-Device Identifier: 00886874125601
• UDI-Public: (01)00886874125601(10)U10250117
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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: U10250117 0081
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 06/14/2025; 04/23/2026
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 07/10/2025; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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: Reuse
• 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