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

Model Number	475205-10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, the force feedback fenestrated bipolar was opened and staff recognized a broken sheath next to the tips.There was no report of patient involvement or reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.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 58.33 mm from the end of the distal tip.The break is located at the distal overmolded end of the main tube.A piece measuring approximately 15.20 mm x 4.14 mm was not returned with the instrument.Components adjacent to the 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.Additional observation not reported by the site: due to the broken main tube, a detached fragment was observed that was not returned with the instrument.The common cause of this failure is attributed to the user.This rma was transferred to engineering for further investigation.
Additional Manufacturer Narrative
Instrument was reviewed by mechanical engineering and their analysis is as follows.The instrument has 2 of 3 uses remaining.The root cause of this rma is user-related damage to the distal overmold of the instrument tube extension.Instrument logs showed that the instrument was successfully used twice.Damage to the instrument can occur due to excessive force or mishandling.
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: 22302558
• Report Number: 2955842-2025-26420
• Device Sequence Number: 18149093
• Product Code: NAY
• UDI-Device Identifier: 00886874120743
• UDI-Public: (01)00886874120743(10)U10250103
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• 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): 04/21/2026

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: 475205-10
• Device Catalogue Number: 475205
• Device Lot Number: U10250103 0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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: Reuse
• 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