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

Model Number	476205-17
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 during a da vinci-assisted hysterectomy surgical procedure, the force feedback fenestrated bipolar forceps tips would not open.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 severely bent grip tip.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause of severely bent grips is attributed to damage during either use or reprocessing, as severe misalignment of grip tips can be due to accidental drops or overloading the tips by applying excessive force.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 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: 24171441
• Report Number: 2955842-2026-02181
• Device Sequence Number: 18658316
• Product Code: NAY
• UDI-Device Identifier: 00886874125588
• UDI-Public: (01)00886874125588(10)U10250310
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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 0115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/26/2026
• 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: Female