MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MEDIUM-LARGE CLIP APPLIER

Model Number	430005-62
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the medium-large clip applier instrument be returned for failure analysis testing.As of the date of this report, the product has not yet been received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the medium-large clip applier instrument did not close.The user completed the procedure using a different backup medium-large clip applier with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the incident with the clip applier occurred while loading the clip onto the device, outside of the patient.The specific issue experienced by the surgeon was that the clip did not close entirely, with the jaws moving but failing to achieve complete closure.The incident occurred during the first clip application of the case.Although the instrument is available for return to intuitive surgical for further evaluation, no photos or videos of the event are available for review.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The medium-large clip applier instrument was found to have the pivoting clamp dislodged from the sector gear.As a result the instrument exhibited imprecise motion.More specifically, the instrument grips failed to open.The root cause of this failure is attributed to user.Additional findings: the instrument was installed on an in-house system and driven.The instrument exhibited imprecise motion.The grip tips moved in the direction commanded, however the grips failed to open.The imprecise motion was a result of the pivoting clamp becoming dislodged from the sector gear.The root cause of this failure is attributed to user.The instrument was found to have a bent drive rod.The drive rod is secured within the pivoting clamp.The root cause of this failure is attributed to user.The instrument will be transferred to engineering for further review.The root cause of this failure is attributed to user.The complaint was confirmed based on the failure analysis.The probable root cause is attributed to the user.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) advanced failure analysis (afa) team re-evaluated the 6mm medium-large clip applier instrument where, initial results were confirmed.The instrument exhibited a dislodged pivot clamp, and the drive rod exhibited a bend.The probable root cause of the dislodged pivoting clamp is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.A dislodged pivot clamp can result in the instrument's jaws being unable to be opened or closed as the pivot clamp needs to be seated in the roll sector gear in order for the grips to be actuated.Correction : h8.Was updated to initial use of device.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MEDIUM-LARGE CLIP APPLIER
• 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: 22584619
• Report Number: 2955842-2025-31354
• Device Sequence Number: 19958680
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(11)240429(10)U10240429(91)0001
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/30/2025

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: 430005-62
• Device Catalogue Number: 430005
• Device Lot Number: U10240429 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 08/27/2025; 10/14/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/21/2025; 09/18/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• 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