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

Model Number	475049-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central processing, the shaft was broken off from the force feedback cadiere forceps.There was no reported patient impact or harm.
Additional Manufacturer Narrative
An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force feedback cadiere forceps instrument was analyzed and the main tube holder was found to be dislodged from its normal position.There were no signs of broken fragments on the main tube holder.The root cause of this failure is currently not established.Further investigation confirmed additional observations.The instrument was found to have a broken chassis where the main tube holder would sit, likely causing the main tube holder to become dislodged.The broken piece remains stuck inside the main tube holder.Components adjacent to this broken chassis do not show damage.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The force feedback cadiere forceps was analyzed and found to have a broken retention tab on the chassis.As a result, the main tube became dislodged from its normal position.The main tube holder did not exhibit any damage.This type of damage typically occurs due to excessive force applied during handling.

• 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: 21024345
• Report Number: 2955842-2024-23679
• Device Sequence Number: 15531425
• Product Code: NAY
• UDI-Device Identifier: 00886874120712
• UDI-Public: (01)00886874120712(10)U10240607
• 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,Followup
• Report Date (Section B): 12/13/2024

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: 475049-10
• Device Catalogue Number: 475049
• Device Lot Number: U10240607 0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/04/2025; 05/20/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/25/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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: Unknown
• 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