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

Model Number	476205-17
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
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.The primary finding of the functional test failure, specifically the sensor failure, was related to the customer-reported complaint.The instrument was found to have sensor failures based on log reviews and this was replicated during in-house testing.The instrument was installed multiple times and failed with error code 22035 p1 = 8, indicating force sensor errors or communication failure on each attempt.These errors suggest either a failure of the instrument to communicate with the system or low-level errors with the instrument's force sensors.A review of logs found multiple instances of error code 22035 with a p1 value of 8, indicating force sensor errors or communication failure.The root cause of this complaint is not determinable.The instrument will be transferred to engineering for further investigation.Additional observations not reported by the site include: the instrument was found to have damaged conductor wire insulation at the yaw pulley.There was fragmentation of the insulation approximately 2.56mm x 0.70mm in size, and the internal conductor wires were damaged and had exposed internal wire, though the internal wire was not frayed or fully broken.Energy was not delivered as it failed engagement on the in-house system.The instrument passed the electrical continuity test.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.Common causes of damaged insulation on instrument conductor wires, particularly bipolar, are attributed to mechanical impacts, such as accidental drops or collisions with other instruments or hard surfaces during handling or use.The complaint was confirmed based on failure analysis, which indicates that the device may have contribute to the customer reported issue.
Event or Problem Description
It was reported that the or staff called to report an issue with force feedback instruments, which had already been reported in a previous service request.The caller mentioned that the surgeon had to try three different bipolar force feedback instruments, all of which were rejected, leading the staff to use a normal bipolar instrument to continue the procedure.The caller did not have additional information about the issue.The technical support engineer reviewed the logs and confirmed the issue, advising that one of the force feedback instruments be returned for failure analysis.The customer reported event has no report of patient injury.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK FENESTRATED 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 ; 4085232100
• MDR Report Key: 23761868
• Report Number: 2955842-2025-48045
• Device Sequence Number: 16038559
• Product Code: NAY
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 476205-17
• Device Catalogue Number: 476205
• Device Lot Number: U10250310 0051
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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