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

Model Number	400180-16
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a robotic-assisted cystectomy procedure, the monopolar curved scissors (mcs) tip cover accessory that was installed on an mcs instrument loosened while inside the patient¿s abdomen.The scrub technician noticed the issue immediately, so the surgeon did not activate the instrument.The scrub technician then removed the mcs instrument, which caused the tip cover accessory to detach completely.However, it is unknown if the mcs tip cover accessory fell inside the patient and was retrieved.Intuitive surgical, inc.(isi) followed up with the initial reporter to obtain additional information; however, no further details are available regarding the reported event.On 12-mar-2026, isi received medwatch report (mdr) with report (b)(4) stating: "while surgery was in progress; robotic cystectomy, the monopolar scissors accessory tip cover came loose while the instrument was inside patient's abdomen.It was noticed right away by the scrub tech; thus, activation of the monopolar scissors was not initiated by surgeon.The scrub tech removed the monopolar scissors from the endowrist that caused the tip to come off completely from the scissors.".
Additional Manufacturer Narrative
A log review cannot be performed due to insufficient event information provided.

• 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: 24818168
• Report Number: 2955842-2026-20742
• Device Sequence Number: 20340419
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)K14250918
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 400180-16
• Device Catalogue Number: 400180
• Device Lot Number: K14250918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White