MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FORCE FEEDBACK; FORCE FEEDBACK PROGRASP FORCEPS

Model Number	476093-17
Medical Device Problem Code	Tactile Prompts/Feedback (4022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci assisted surgical procedure, potential errors occurred repeatedly.After 3 retries, a different force feedback arm was recognized and normal operation was confirmed.The corresponding arm is not being recognized; this is presumed to be an error issue.The customer reported event has no report of patient injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Failure analysis investigations replicated and confirmed the customer-reported complaint.Failure analysis found that the primary failure, a dislodged z sensor coil, was related to the reported complaint.The investigation identified (b)(6) in the logs, indicating that the user experienced an installation error.The instrument was inspected and the z sensor coil was found to be dislodged.This type of damage typically occurs when a large force is applied to the instrument in a mishandling or misuse scenario.A visual inspection was completed and no damage was observed to any proximal end components.Manual articulation of the input discs was performed and issues were present.The instrument was installed multiple times and failed recognition due to bias shift.Additional findings not reported by the site: the instrument was found to have a broken main tube approximately 7.04 mm from the distal tip.No material was found to be missing.Components adjacent to the broken main tube did not show damage.Common causes of the failure mode ¿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 inward, causing it to crack and subsequently break.The instrument was also found to have a detached fragment, which resulted from the broken main tube.The missing piece was returned with the instrument.The root cause of this failure is attributed to user handling.
Additional Manufacturer Narrative
The probable root cause of broken main tube and detached fragment is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.This issue can be resolved by using an alternate instrument to complete the procedure.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK PROGRASP FORCEPS
• 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: 25105105
• Report Number: 2955842-2026-23899
• Device Sequence Number: 13447952
• Product Code: NAY
• UDI-Device Identifier: 00886874125595
• UDI-Public: (01)00886874125595(11)251106(10)K10251106
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/19/2026

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: 476093-17
• Device Catalogue Number: 476093
• Device Lot Number: K10251106 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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