MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; TIP COVER ACCESSORY

Model Number	400180-14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The monopolar curved scissors (mcs) tip cover accessory has not been received for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip cover became loose, falling into the cavity twice even after repositioning.The mcs tip cover was torn.The procedure was completed.A fragment fell into the patient, however it was unknown if it was retrieved.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: DA VINCI
• Common Device Name: TIP COVER ACCESSORY
• 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: 24776383
• Report Number: 2955842-2026-20357
• Device Sequence Number: 12295574
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)K10240717
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: K10240717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown