MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CURVED SCISSORS

Model Number	430004-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) instrument was analyzed and found to have a broken tube adapter.This component is located at the distal end of the instrument and serves as the interface between the instrument and the user installed tip accessory.The broken piece, measuring approximately 1.8mm x 3.8mm and was not returned with the instrument.Additionally, the instrument was found to have a detached fragment.Visual inspection was performed and the detached fragment was broken from the tube adapter.The area of the detached fragment measures approximately 1.8mm x 3.8mm in size.The probable root cause of a damaged tube adapter is attributed to either tip accessory installation issues or damage during use.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, the monopolar curved scissors instrument retaining clip at the instrument tip was broken.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) instrument was analyzed and found to have a broken tube adapter.Visual inspection was performed and there was no damage to the snake wrist cables, shaft and housing.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CURVED SCISSORS
• 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: 24811630
• Report Number: 2955842-2026-20348
• Device Sequence Number: 12250180
• Product Code: NAY
• UDI-Device Identifier: 00886874114285
• UDI-Public: (01)00886874114285(11)250729(10)K10250729
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 430004-62
• Device Catalogue Number: 430004
• Device Lot Number: K10250729 0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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