MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CLIP APPLIER, SMALL, HORIZON

Model Number	470401-05
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the small horizon clip applier instrument to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The instrument was found to have grip input shaft axis #6 broken into pieces inside the housing.As a result of the fully broken inputs, functional testing for motion related issues could not be performed.The input disk, bearing and the retaining ring belong to input axis #6 were still intact.The probable root cause is attributed to damage during reprocessing.Leftover residual chemicals on the input shaft can result in cracking at high temperatures of the autoclave.Insufficient flushing/rinsing steps at the end of the cleaning process can also result in a damaged instrument input shaft.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the small horizon clip applier instrument turned 90 degrees while clipping.The procedure was completed and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) contacted the customer and obtained the following information: this issue occurred with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer and while the surgeon was attempting to manipulate the instrument from the surgeon console.The instrument was not static, and the movement of the instrument scaled appropriately with the surgeons.The instrument moved in the intended direction and the timing of the instrument had no delay.No shakiness was observed and there was no instrument-to-instrument or system arm-to-arm interference.There were no external collisions.The issue was persistent and the customer used a back-up clip applier.

• Brand Name: ENDOWRIST
• Common Device Name: CLIP APPLIER, SMALL, HORIZON
• 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: 24640669
• Report Number: 2955842-2026-16542
• Device Sequence Number: 13235348
• Product Code: NAY
• UDI-Device Identifier: 00886874112670
• UDI-Public: (01)00886874112670(10)T10171107
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150837
• 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
• Report Date (Section B): 03/19/2026

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: 470401-05
• Device Catalogue Number: 470401
• Device Lot Number: T10171107 0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2017
• 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