MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TIP COVER ACCESSORY

Model Number	400180-16
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2025
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, an monopolar curved scissors (mcs) tip cover accessory fell inside the patient.A patient who had a case on (b)(6) 2025, recently took a computed tomography (ct) image and found that something like a tip cover was reflected.It could not be confirmed by intraoperative x-rays, but when the customer checked the intraoperative video, and confirmed the image of the tip cover falling off.The patient's condition is unknown at this time.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: based on the surgical case involving the mcs tip cover accessory, the hospital provided a clear explanation to the patient regarding the accessory¿s status.With the patient¿s informed consent, no additional surgical procedure was performed to retrieve the mcs tip cover accessory; instead, the patient is currently under observation.There is no plan to remove or return the tip cover because the fragment was not retrieved as the surgery was not performed.Whether the mcs instrument collided with other instruments, if the tip cover accessory was properly installed, whether any part of the orange surface was visible post-installation, if lubricant was applied before installation, if there was difficulty in removing the instrument and tip cover, if the wrist was straightened upon removal, whether any damage was noted to key components, and whether the instruments or accessories are available for return to intuitive surgical¿these details remain unknown.The patient will continue to be monitored for any further developments.Further investigation was performed by the customer, and the misalignment of tip cover was confirmed in video footage taken approximately two hours after the start of procedure.Subsequently, it was confirmed that the wrist of mcs was bent when it detached.

• Brand Name: NONE
• 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: 25081902
• Report Number: 2955842-2026-23870
• Device Sequence Number: 10532891
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)K14250313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112263
• 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
• Report Date (Section B): 05/05/2026

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: K14250313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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 Sex: Unknown