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	Foreign Body In Patient (2687)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.A return material authorization (rma) had been issued requesting to have the isi device returned; however, isi did not receive the rma to confirm/identify the failure mode.Although the complaint was not confirmed by failure analysis since the product was not returned, the information gathered indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip broke inside of the patient.A fragment fell into the patient.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 nothing unusual was noted; the tip was properly mounted and functioned normally when tested for movement.The instrument was not moving properly so the arm was withdrawn.At that point, the tip had already separated and remained inside of the patient when the arm was removed.It is unknown what the surgeon believed was the cause of the instrument's breaking.The customer did not recall how long the instrument was in use for but stated that it was not used for a long time.The surgeon recognized that the tip had separated and remained inside of the patient.The instrument did not collide with any other instruments or other hard materials during the surgical procedure.The fragment did not fall instead of the patient during an instrument tip collision.The mcs tip became dislodged during the instrument removal.It is unknown if the staff felt any resistance while moving the instrument through the cannula.The fragment was not found and was not removed.No additional surgical procedure was required.Ultrasound, x-ray, and computed tomography (ct) scans were performed.The procedure was completed robotically.It is unknown if the patient returned to the hospital due to experiencing any post-surgical complications related to a foreign object.It is unknown if the instrument or the tip will be returned for our analysis.; no fragments will be returned.There are no photographic images of the device or video recordings of the procedure available for outside review.

• 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: 21967339
• Report Number: 2955842-2025-17441
• Device Sequence Number: 20861129
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(17)261031(10)K10241024
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430035-13
• Device Catalogue Number: 430035
• Device Lot Number: K10241024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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: Reuse
• 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