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	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
It was reported that during a da vinci¿assisted partial nephrectomy, the tip cover accessory from the monopolar curved scissors (mcs) was reported to have dislocated into the abdominal cavity.The tip cover accessory was retrieved during the same procedure using laparoscopic forceps.No patient injury was reported.It is unknown whether the mcs instrument collided with other instruments.The tip cover accessory appeared to have been properly installed, with no orange surface visible after installation, and no electrolube or other lubricant was applied prior to installation.Any resistance or difficulty during instrument removal was unknown, and it was also unknown whether any damage to the tip cover accessory, mcs instrument, or cannula was noted after the event.No additional surgical procedure was required to remove the fragment, and no post-operative imaging (e.G., x-ray or ultrasound) was performed to assess for retained fragments.The patient had not returned due to any post-surgical complications related to the event.
Additional Manufacturer Narrative
Device evaluation: intuitive surgical, inc.(isi) received the monopolar curved scissor (mcs) tip cover accessory to perform failure analysis.Using an installation tool, the mcs tip cover accessory was placed on an mcs instrument.The mcs tip cover accessory was loosely attached to the scissors and could be removed easily with little effort.An additional observation not reported by customer was that the mcs tip cover accessory was found to have tearing 25-31 mm from the proximal end where the instrument inserts.The tears were axially aligned with the tip cover accessory and measured from 1mm to 3mm in length.There were no signs of thermal damage present at the end of any of the tears.
Additional Manufacturer Narrative
The monopolar curved scissors (mcs) tip cover accessory has not been received for failure analysis evaluation.

• 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 ; +1(408)523-2100
• MDR Report Key: 50155739
• Report Number: 2955842-2026-34793
• Device Sequence Number: 9103415
• 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,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 400180-16
• Device Catalogue Number: 400180
• Device Lot Number: K15250403
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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