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

Model Number	470401-07
Medical Device Problem Codes	Unintended Movement (3026); Failure to Eject (4010)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the small clip horizon applier instrument experienced unintended motion, resulting in additional bleeding.It was noted that the cables or "spring" had snapped/broken and the instrument jerked to the left.While the surgeon was attempting to apply a clip to a small bronchial bleeder at a lymph node site, the clip applier instrument reportedly rotated 90 degrees rather than deploy the clip as intended.The surgeon indicted the deployment was supposed to be straightforward and non-obstructed.The unintended instrument motion resulted in tissue trauma, which led to additional bleeding.Hemostasis was controlled with direct pressure, application of surgicel, and then additional pressure.Reported blood loss was less than 5ml.The surgeon then switched to using the vessel sealer instrument.The patient has been discharged and has not had any post-operative complications.
Additional Manufacturer Narrative
The small clip horizon applier instrument used during this event was not received for failure analysis investigations.

• 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 ; +1(408)523-2100
• MDR Report Key: 50164319
• Report Number: 2955842-2026-34512
• Device Sequence Number: 14772012
• Product Code: NAY
• UDI-Device Identifier: 00886874112670
• UDI-Public: (01)00886874112670(11)230928(10)K10230928
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 470401-07
• Device Catalogue Number: 470401
• Device Lot Number: K10230928 0050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2023
• 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: ISIFA2022-05-C, ISIFA202
• 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