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

Model Number	475093-15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Failure analysis investigations replicated/confirmed the customer's reported complaint.The instrument was found to have a broken main tube approximately 87.61 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 6.81 mm x 3.91 mm in size, 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 inward, 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 user mishandling.This rma will be transferred to engineering for further investigation.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, the force feedback prograsp forceps plastic tip broke.The procedure was completed with no reported 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.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Instrument was reviewed by mechanical engineering and their analysis is as follows: the instrument has 2 of 4 uses remaining.The root cause of this rma is related to user misuse, which resulted in damage to the instrument main tube (pn (b)(6)) at the distal overmolded section.Phone notes indicate that the instrument was damaged after the procedure.The extent of this damage typically occurs due to excessive loading conditions.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.Field h8 corrected to initial use.

• Brand Name: FORCE FEEDBACK
• Common Device Name: FORCE FEEDBACK PROGRASP 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: 21965463
• Report Number: 2955842-2025-18836
• Device Sequence Number: 8111772
• Product Code: NAY
• UDI-Device Identifier: 00886874125434
• UDI-Public: (01)00886874125434(10)U10240816
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 475093-15
• Device Catalogue Number: 475093
• Device Lot Number: U10240816 0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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