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

Model Number	470183-19
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the permanent cautery hook instrument to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The instrument was found to have a dislodged cautery hook at the distal end.The hook is not fully intact at the molded insulator and as a result energy delivery is observed in an unintended location.Smoke was observed coming from the distal clevis during the energy delivery test.The root cause for the failure is not established.
Event or Problem Description
It was reported the permanent cautery hook instrument was twisted and loose.There was no report of any patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter to obtain additional information; however, no further details are available regarding the reported event.

• Brand Name: EndoWrist
• Common Device Name: PERMANENT CAUTERY HOOK
• 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: 50942439
• Report Number: 2955842-2026-40384
• Device Sequence Number: 9498722
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/29/2026

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: 470183-19
• Device Catalogue Number: 470183
• Device Lot Number: K10260416 0181
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2026
• 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