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

Model Number	400180
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
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 benign hysterectomy procedure, the monopolar curved scissors (mcs) tip cover accessory, installed on an mcs instrument, fell off inside the patient¿s body.The mcs tip cover accessory was retrieved without complications during the same procedure.The customer indicated that excessive lubrication may have contributed to the mcs tip cover accessory dislodging.The procedure was completed as planned.Intuitive surgical, inc.(isi) has attempted to gather additional information regarding the reported event; however, no response has been received.

• 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: 25294303
• Report Number: 2955842-2026-26333
• Device Sequence Number: 13156560
• Product Code: NAY
• UDI-Device Identifier: 00886874111048
• UDI-Public: 00886874111048
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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
• Device Catalogue Number: 400180
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female