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

Model Number	476049-17
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, the force feedback cadiere forceps instrument was damaged.There was no report of patient involvement or patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The force feedback cadiere forceps instrument was analyzed and found to have a broken chassis; the t-tabs located on the bottom part of the chassis were broken.The broken piece was not returned measuring roughly 0.255¿ x 0.104¿ in size.Components adjacent to this broken chassis show damage.As a result of the broken chassis t-tabs, the main tube assembly was found to be dislodged from its normal position.There was no damage observed to the main tube.Additionally, the instrument was found to have a broken main tube holder.A broken piece of the main tube holder measuring approximately 0.119¿ x 0.086¿ in size 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 instrument was found to have a broken tube extension at the distal overmold section.Broken piece of roughly 0.371¿ x 0.299¿ in size was not returned with the instrument.Bent inner main tube was also observed because of the broken tube extension.The complaint regarding instrument damaged in central processing was confirmed by failure analysis.The probable root cause is attributed to damage during use or reprocessing.Damage can result from mechanical impact, such as an accidental drop of the instrument.

• 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: 24284452
• Report Number: 2955842-2026-03624
• Device Sequence Number: 8580538
• Product Code: NAY
• UDI-Device Identifier: 00886874125564
• UDI-Public: (01)00886874125564(10)U12250520
• 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): 02/06/2026

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: U12250520 0136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 02/06/2026
• 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