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

Model Number	400180-16
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The reported event with the tip cover accessory could not be replicated nor confirmed.Using the installation tool, the tip cover was placed on a monopolar curved scissor instrument.The tip cover was tightly attached to the scissor and could only be removed with considerable effort.No product issue was identified.Based on the investigation results, customer reported issues may be due to other factors unrelated to the product.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the forceps were properly fitted, but when the scissors were removed from the port, the monopolar curved scissors (mcs) tip cover accessory came off and remained inside the port.It was retrieved during the same procedure.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: during the surgical event, it remains unknown how the mcs tip cover accessory was retrieved, whether the mcs instrument collided with other instruments, if any lubricant was applied before installation, whether there was difficulty in removal, whether the instrument wrist was straightened prior to removal, or if any immediate damage was observed on the accessory, instrument, or cannula.However, it was noted that the tip cover accessory appeared to be properly installed, with no part of its orange surface visible after installation, which is consistent with recommended practice for ensuring electrical insulation and safety.The tip cover accessory has been returned to intuitive surgical for further evaluation, though the accompanying mcs instrument was not sent back.No fragment was noticed.

• 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: 24859356
• Report Number: 2955842-2026-21283
• Device Sequence Number: 16089410
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)K15250403
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: K15250403 NA
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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