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

Model Number	476205-17
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument was broken.The customer reported event has no report of patient injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations replicated and confirmed the customer-reported complaint.Failure analysis found the primary failure of the broken main tube to be related to the customer-reported complaint.The instrument was found to have a broken main tube approximately 0.26" from the distal tip.A piece measuring approximately 0.38¿ x 0.17¿ was not returned with the instrument.Components adjacent to this broken main tube do not show damage.Common causes of the failure mode "broken instrument main tube" are 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, causing it to crack and subsequently break.The complaint was confirmed based on failure analysis, which indicates that the device may have contribute to the customer reported issue.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.This issue can be resolved by using an alternate instrument to complete the procedure.

• 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: 23599712
• Report Number: 2955842-2025-45709
• Device Sequence Number: 21161604
• Product Code: NAY
• UDI-Device Identifier: 00886874125588
• UDI-Public: (01)00886874125588(10)U10250613
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 11/19/2025

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: U10250613 0186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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