MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; MONOPOLAR CURVED SCISSORS (MCS) TIP

Model Number	430035-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted malignant nipple sparing mastectomy with autologous reconstruction surgical procedure, the customer found out that the tip of the monopolar curved scissors (mcs) tip was broken.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the clinical sales associate (csa) and obtained the following additional information: the customer reported that the mcs connector pin was broken and the customer clarified that the connector pin had broken off.The customer also confirmed that the scissors accessory was broken and reported that a fragment broke off of the scissors blade.The customer confirmed that the mcs tip was inspected prior to use.The procedure was a single port (sp) mastectomy.The customer confirmed that the procedure was completed with a backup mcs tip.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the monopolar curved scissors (mcs) tip accessory involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors instrument was analyzed and found to have a broken instrument tube adapter.This component is located at the distal end of the instrument and serves as the interface between the instrument and the user installed tip accessory.The broken piece was not returned and measured approximately 1.22mm x 2.16 in size.The instrument was found to have a detached fragment.The fragment broke off from the instrument¿s tube adapter.The mcs tip was found to have a dislodged retaining tip cover from the mcs blades.The retaining tip cover was observed detached from the blades.No material appears to be missing.The mcs retaining tip cover was found to have cracking damage.No material appears to be missing.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage from mishandling/misuse, which may include improper handling of the cable during either use or reprocessing.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• 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: 24973949
• Report Number: 2955842-2026-22704
• Device Sequence Number: 17382040
• Product Code: NAY
• UDI-Device Identifier: 10886874114374
• UDI-Public: (01)10886874114374(10)K10250731
• 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): 05/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430035-13
• Device Catalogue Number: 430035
• Device Lot Number: K10250731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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.
• Patient Sex: Unknown