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

Model Number	470401-07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the clips from a horizon small clip applier instrument would loosen and fall off when gripped.The instrument's jaws/grips were not damaged.The instrument's grips were reportedly weak and would not hold the clips.The clips were retrieved by the assistant nurse with the camera.No additional surgical procedures, such as laparoscopy or open surgery, were necessary for removal, and no post-operative imaging such as an x-ray or ultrasound were conducted to check for remaining fragments.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
The horizon small clip applier instrument has been received a for failure analysis evaluation.However, the failure analysis investigation has not been completed at the time of this report.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The horizon small clip applier instrument was received for failure analysis.The reported event with the instrument could not be replicated nor confirmed.The instrument was placed and driven on an in-house system: the instrument passed the recognition and engagement tests and moved intuitively with full range of motion in all directions.The instrument jaws opened and closed properly.The clip test was done three times in different positions and passed each time.The instrument was fully functional.No product issue was identified.

• 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: 24942830
• Report Number: 2955842-2026-21909
• Device Sequence Number: 12993599
• Product Code: NAY
• UDI-Device Identifier: 00886874112670
• UDI-Public: (01)00886874112670(11)240327(10)K10240327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150837
• 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): 05/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 470401-07
• Device Catalogue Number: 470401
• Device Lot Number: K10240327 0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown