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	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the medium-large clip applier instrument involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted partial nephrectomy - retroperitoneal anterior surgical procedure, the single port medium-large clip applier would not open; the clip could be loaded but could not clip into the patient.Then, the single port medium-large clip applier would not open and could only be opened manually.No fragment fell into the patient.The user completed the procedure, and no known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The medium-large clip applier instrument was analyzed and found to have a dislodged pivoting clamp from the grip sector gear.This failure likely caused the imprecise motion observed during in-house testing.Failure analysis found the secondary failure of imprecise motion to be related to the customer reported complaint.The instrument was installed on an in-house system and driven.The instrument exhibited imprecise motion in the grip open and close function.The grip tips moved in the direction commanded; however, the grip tips were unable to open or close.The instrument was unable to open and close its jaws when actuating the manual grip knob off the system.The instrument was found to have the proximal drive rod bent.This rma will be transferred to engineering for further investigation.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 or hard surfaces.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
After further investigation of the failure analysis team, there were no additional findings; however, it was noted that the bend of the drive rod appears to bend towards the left when viewing the instrument's nose area with the housing removed and the main tube upwards.This observation was of interest as a second clip applier with a dislodged pivot clamp was also bent in the same direction.
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: 22310944
• Report Number: 2955842-2025-26507
• Device Sequence Number: 12743857
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(11)240620(10)K10240620
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K182371
• 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,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: 430005-62
• Device Catalogue Number: 430005
• Device Lot Number: K10240620 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 03/31/2026
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/05/2025; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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: 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