MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; MONOPOLAR CURVED SCISSORS (MCS) TIP

Model Number	430035-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mcs tip has been received for failure analysis evaluation; however, the investigation had not been completed at the time of this report.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the single port (sp) monopolar curved scissors (mcs) tip kept falling from the mcs instrument.The mcs tip fell into the patient and 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: the instrument was inspected prior to use, and no damage was noted.The surgeon believed the instrument was damaged during the surgery; it was used for 5 minutes.The surgeon noticed that the tip had dropped.Instrument did not collide with any other instruments or the hardware material during the surgical procedure.The fragment didn't fall inside of the patient during an instrument tip or accessory collision.The instrument was not removed during the procedure prior to the breakage.Upon final removal of the instrument the wrist was straightened.No damage was noted to the instrument, or the cannula upon final removal.However, the surgical staff noticed that the connector of the instrument was damaged.The assistant retrieved all fragments and confirmed that nothing was left behind.No additional surgical procedure was required to remove the fragment.There were no post operative tests like an x-ray, or ultrasound performed to check for remaining fragments.The procedure was completed robotically.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The instrument and the fragment were available for return.There were no images, or video recordings of the procedure available for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) instrument was analyzed and found to have a dislodged retaining tip cover from the mcs blades.The retaining tip cover was observed to be completely detached from the blades.No material appeared to be missing.Due to the dislodged retaining cover, a detached fragment was observed that was returned with the mcs tip accessory.The retaining cover measured approximately 7.30mm x 13.90mm in size.The retaining cover was found to be torn at the distal end.The tear measured approximately 1.36mm in length.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI
• Common Device Name: MONOPOLAR CURVED SCISSORS (MCS) TIP
• 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: 23291679
• Report Number: 2955842-2025-40798
• Device Sequence Number: 10028458
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(17)270228(10)K10250213
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182371
• 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,Followup
• Report Date (Section B): 11/14/2025

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: 430035-13
• Device Catalogue Number: 430035
• Device Lot Number: K10250213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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