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

Model Number	431100-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The single port (sp) extended range monopolar curved scissors was returned and evaluated by the failure analysis (fa) team.The instrument was found to have a broken instrument 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 was not returned and measures approximately 1.61mm x 2.56 mm in size.The electrical continuity was performed and passed.The inputs were manually articulated and passed.The housing was removed and found to be undamaged.The instrument was found to have a detached fragment.The detached fragment was from the broken instrument tube adapter but not returned.The detached fragment measures approximately 1.61 mm x 2.56 mm.The root cause is typically attributed to mishandling.
Event or Problem Description
It was reported that the single port (sp) extended range monopolar curved scissors had a broken tip.There was no report of patient involvement or reported injury.Intuitive surgical, inc.(isi) made a follow-up attempt to obtain additional information.However, no further details could be provided and obtained the following: the customer reported that they did not have any more information, other than what was originally offered.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CURVED SCISSORS ER
• 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: 25037250
• Report Number: 2955842-2026-23317
• Device Sequence Number: 16033617
• Product Code: NAY
• UDI-Device Identifier: 00886874124048
• UDI-Public: (01)00886874124048(10)K10251211
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• 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): 04/29/2026

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: 431100-02
• Device Catalogue Number: 431100
• Device Lot Number: K10251211 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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