MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; PERMANENT CAUTERY SPATULA

Model Number	470184-17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the permanent cautery spatula instrument articulation/joint was broken.The procedure was completed with no reported injury.Intuitive followed up and obtained additional information via customer checklist.Issue was broken part at the articulation and joint of the instrument.There were five lives left.Procedure was on (b)(6)2026.Procedure was a robotic treatment of endometriosis and lysis of adhesions.A backup instrument was used and no patient harm.Nothing fell in the patient.
Additional Manufacturer Narrative
The permanent cautery spatula (pcs) instrument has been returned and evaluated by the failure analysis team.Intuitive has received the part associated with this complaint and completed investigations.Fa investigations replicated confirmed the customer reported complaint.The pcs instrument was found to have a broken distal clevis at the ears of the clevis.The broken piece was not returned.Clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis show damage which may indicate potential misuse.Additionally, the pcs instrument was found to have a broken monopolar yaw pulley at the ceramic insulator interface.Broken pieces are missing as a result of breakage.The components surrounding the break did exhibit damage that would have contributed to the broken yaw pulley.The instrument conductor cap was found to be broken.As a result of the break these components are considered detached fragments.The detached pieces were not returned with the instrument.The instrument was found to have the monopolar conductor wire/dislodged from its original position.The probable root cause is attributed to use conditions.

• Brand Name: EndoWrist
• Common Device Name: PERMANENT CAUTERY SPATULA
• 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: 50928008
• Report Number: 2955842-2026-40299
• Device Sequence Number: 18831074
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• 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
• Report Date (Section B): 09/28/2026

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: 470184-17
• Device Catalogue Number: 470184
• Device Lot Number: K10251229 0072
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2025
• 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