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

Model Number	470184-16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the permanent cautery spatula instrument to perform failure analysis (fa).The instrument was found to have a broken distal clevis at the base of the clevis.The broken piece was not returned, measuring roughly 0.32¿ x 0.20¿ in size.Clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis show damage which may indicate potential mishandling/misuse.The monopolar cap is missing.The probable root cause is attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Instrument collisions with other hand-held instrumentation or instrument driven outside the field of view can also cause damage to the instrument distal clevis.Additional observation(s) related to customer complaint: the instrument was found to have a completely broken grip and missing conductor cap.The missing piece was not returned and measure approximately in size 0.19¿ x 0.25.¿ during investigation, fa found that the instrument had a dislodged conductor wire at distal end.The conductor cable was loose and hanging.This is a result of a completely broken and missing conductor cap and distal clevis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tip of a permanent cautery spatula instrument has been damaged.The procedure was completed with no reported injury.

• 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 ; 4085232100
• MDR Report Key: 25179993
• Report Number: 2955842-2026-25178
• Device Sequence Number: 10543784
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(11)250206(10)K10250206
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 470184-16
• Device Catalogue Number: 470184
• Device Lot Number: K10250206 0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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