MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC Force Feedback; Force Feedback Maryland Bipolar Forceps

Model Number	476172-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer experienced an issue with an intuitive product.The customer reported event has no report of patient injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
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 determined that the primary failure a function test failure due to sensor failure was related to the customer reported complaint.The instrument was found to have sensor failures based on log review, which were replicated in-house.The instrument was installed multiple times on the in house system for testing and failed on each attempt.A review of the logs found error code 22035 with a p2 value of 112, which indicates that error flags were generated by the instrument pca board.A visual inspection was completed and no damage was observed to any proximal end components.The root cause of this failure is not determinable.Additional findings not reported by site: the instrument was found to have various scratches on the main tube.Scratches and abrasions on the main tube are deemed cosmetic damage.The scratches measured approximately 1.660", 0.062" in length and are not axially aligned with the tube axis.Material is not missing from the surface of the main tube, and components adjacent to the scratched main tube show no damage.Common causes of the failure mode scratch marks and abrasions on the instrument main tube are attributed to user handling, which can result from instrument collisions, abrasive instrument cleaning, instrument cleaning inside the body, or normal wear over time due to friction against the cannula.

• Brand Name: Force Feedback
• Common Device Name: Force Feedback Maryland Bipolar 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 ; +1(408)523-2100
• MDR Report Key: 50216671
• Report Number: 2955842-2026-35278
• Device Sequence Number: 20364181
• Product Code: NAY
• UDI-Device Identifier: 00886874125571
• UDI-Public: (01)00886874125571(11)260610(10)K10260610
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 476172-17
• Device Catalogue Number: 476172
• Device Lot Number: K10260610 0047
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2026
• 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