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

Model Number	475006-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is pending to determine the cause of this reported event.An rma was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that the customer experienced a cracked shaft.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.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback instrument was analyzed and found to have a cracked main tube.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is 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 leading to cracking.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 LARGE 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: 24338993
• Report Number: 2955842-2026-04259
• Device Sequence Number: 20026368
• Product Code: NAY
• UDI-Device Identifier: 00886874120705
• UDI-Public: (01)00886874120705(10)U10250102
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 475006-10
• Device Catalogue Number: 475006
• Device Lot Number: U10250102 0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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