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

Model Number	476049-17
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback cadiere forceps instrument was analyzed and found to have a cracked tube extension at the brown laser marked section of the component.There were no broken pieces.Thermal damage was not observed.There were two cracks observed, and the crack(s) measured 0.4520" and 0.5065" in length.The complaint was confirmed by failure analysis.An image review was performed by an intuitive surgical, inc.(isi) fae.The following additional information was provided: based on the photos, it does look like a triangular shaped piece is missing from the distal overmolded section of the main tube.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 or hard surfaces.
Event or Problem Description
It was reported that the force feedback cadiere forceps instrument dropped on the floor and cracked at the distal end.No known impact or patient consequence was reported.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK CADIERE 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: 24226257
• Report Number: 2955842-2026-02833
• Device Sequence Number: 21148649
• Product Code: NAY
• UDI-Device Identifier: 00886874125564
• UDI-Public: (01)00886874125564(10)U10250520
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/30/2026

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: 476049-17
• Device Catalogue Number: 476049
• Device Lot Number: U10250520 0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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