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	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medium-large clip applier instrument was received, and failure analysis confirmed/replicated the reported event.The clamp pivoting grip rod was dislodged which likely caused the imprecise movement.The housing was removed for inspection and found the component holding the drive rod dislodged from the usual place.This causes the drive rod to become stationary when articulating the grip knob.Visual inspection was performed and found no external damage to the shaft or housing.Although the instrument moved intuitively with full range of motion in all directions, while manipulating with the master tool manipulator (mtm), the grips failed to open and exhibited imprecise motion while gripping.Unrelated to the event, the instrument was also found to have corroded pulley cables.When the housing of the instrument was opened up, the pulley cables exhibited a white substance indicative of corrosion.
Event or Problem Description
It was reported that during a da vinci-assisted retroperitoneal nephrectomy procedure, the medium-large clip applier instrument closed and applied a clip to the renal artery but became stuck on the vessel.The customer reported that the release wheel did not work to open the jaws.The customer was able to get it off the vessel and the procedure was completed as planned with no reported patient injury or complication.The instrument was inspected after this event occurred and the customer did not observe any damage or issues other than the wheel at the back of the instrument to open the instrument jaws did not move when manipulated.

• 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: 23703848
• Report Number: 2955842-2025-47063
• Device Sequence Number: 18814365
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(11)241023(10)U10241023(91)0007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: U10241023 0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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