MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; REDUCER

Model Number	470381-12
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the reducer to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The reducer was found to have a tear on the blue rubber duckbill.The torn piece was missing and was not returned with the reducer.Common causes may be attributed to damage during various handling points, including manufacturing, installation, or use.Root cause was not established.Additional observation(s) not reported by site: the reducer exhibits scratch marks on the top surface of the reducer.There was no material missing.This failure is likely caused by instruments scratching the surface of the reducer upon insertion or removal.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the valve was damaged (chipped) on a reducer.The procedure was completing as planned with no reported injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The probable root cause of the tears/torn reducer and the and the torn piece are attributed to damage during various handling points, including manufacturing, installation, or use.The probable root cause of the scratch marks is attributed to the instruments scratching the surface of the reducer upon insertion or removal.

• Brand Name: ENDOWRIST
• Common Device Name: REDUCER
• 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: 22379103
• Report Number: 2955842-2025-28487
• Device Sequence Number: 15528937
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(17)260531(10)K11240523
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2025

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: 470381-12
• Device Catalogue Number: 470381
• Device Lot Number: K11240523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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