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

Model Number	476049-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the 8mm force feedback cadiere forceps instrument to perform failure analysis.The instrument was analyzed and found to have a broken main tube approximately 0.2785" from the distal tip.A piece measuring proximately 0.2815¿ x 0.11¿ was not returned with the instrument.Components adjacent to this broken main tube show damage which may indicate potential mishandling/misuse such as scratch marks/abrasions near distal tip.Additional observations related to the customer reported complaint: the instrument was found to have the main tube holder broken.Pieces of the main tube holder measuring approximately 2.49mm x 1.51mm and 3.59mm x 1.67mm was not returned with the instrument.As a result of the broken main tube holder, the main tube assembly was found to be dislodged from its normal position.The complaint was confirmed by failure analysis.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 and subsequent breakage.
Event or Problem Description
It was reported that during central processing, the 8mm force feedback cadiere forceps instrument tip was damaged.There was no report of patient involvement or patient injury.

• 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: 24225321
• Report Number: 2955842-2026-02827
• Device Sequence Number: 8392815
• Product Code: NAY
• UDI-Device Identifier: 00886874125564
• UDI-Public: (01)00886874125564(10)U10250507
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: U10250507 0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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