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

Model Number	400180-16
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the scrub nurse reported that the silicone tip of the tip cover accessory was ruptured and proceeded to exchange it for a new one.The robotic coordinator reported that this was the fourth tip cover from the same lot to exhibit similar damage.The procedure was completed with no reported injury.

• 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 ; +1(408)523-2100
• MDR Report Key: 50229490
• Report Number: 2955842-2026-35549
• Device Sequence Number: 13326100
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)K12260226
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K112263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 400180-16
• Device Catalogue Number: 400180
• Device Lot Number: K12260226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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
• Patient Sex: Unknown