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

Model Number	475309-15
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
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 functional test failed recognition failure to be related to the customer reported complaint.The instrument housing was removed for visual inspection, and it was found that the rfid retainer and identification board were dislodged from its normal position.The identification board and rfid retainer were found loose 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 instrument was installed multiple times on an in-house system and failed the recognition test due to the rfid becoming dislodged.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.Further investigation confirmed additional observations.The instrument was found to have a broken main tube approximately 1.342" from the distal tip.A piece measuring proximately 12.79mm x 6.75mm was not returned with the instrument.Components adjacent to this broken main tube do not show damage.Common causes of the broken 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.Excessive side loading on the instrument can also cause the main tube wall to collapse inwards causing it to crack and subsequently break.The instrument was found to have a detached fragment.The detached fragment was the result of the crack on the main tube.The missing piece was not returned with the instrument.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the force feedback mega suturecut needle driver would not engage.The procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the instrument arm was never engaged in the patient.There was no report of fragments falling from the device while used within a patient as the instrument was not used or entered inside the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.
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: 24552406
• Report Number: 2955842-2026-15500
• Device Sequence Number: 5573433
• Product Code: NAY
• UDI-Device Identifier: 00886874125458
• UDI-Public: (01)00886874125458(10)U10241226
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• 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): 03/23/2026

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: 475309-15
• Device Catalogue Number: 475309
• Device Lot Number: U10241226 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2024
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic