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

Model Number	470401-12
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no patient injury, and the clip did not become dislodged from the instrument and fall into patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the horizon small clip applier instrument involved with the alleged issue to perform failure analysis; however, failure analysis is still in progress.A follow-up mdr will be submitted once the product is evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer had difficulty in moving the horizon small clip applier instrument.The procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The horizon small clip applier instrument was analyzed and found to have a grip cable dislodged at the proximal end.The complaint was confirmed by failure analysis.The probable root cause is attributed to a loss of cable tension.A cracked clamping pulley and/or input shaft can cause the cable to become dislodged at the proximal end.When the clamping pulley and/or input shaft is cracked, the cable can dislodge as the input could ""slip"" with respect to its internal shaft causing the loss of cable tension.A cracked clamping pulley and/or input shaft can be caused by improper cleaning or sterilization techniques used during reprocessing.A dislodged cable at the proximal end can then result in the cable becoming derailed or loose at the distal end.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24470255
• Report Number: 2955842-2026-05290
• Device Sequence Number: 9643842
• Product Code: NAY
• UDI-Device Identifier: 00886874112670
• UDI-Public: (01)00886874112670(11)241128(10)K10241128
• 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,Followup
• Report Date (Section B): 04/03/2026

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: 470401-12
• Device Catalogue Number: 470401
• Device Lot Number: K10241128 0359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/01/2026
• Supplement Date Received by Manufacturer: 02/01/2026; 03/11/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/02/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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