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	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted gynecology myomectomy surgical procedure, the 8mm monopolar curved scissors (mcs) instrument tip was dislocated from instrument and the plastic ring was separated from the tip.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) obtained the following additional information: the instrument was not inspected prior to use.There was no damage noticed.There was no thermal damage or arcing observed.There was no patient injury.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the sp monopolar curved scissors tip accessory for failure analysis investigation.The accessory was analyzed and found to have a damaged retaining cover.The retaining cover and metal accessory were returned detached.Upon visual inspection, damage was found at the retaining cover.There were no missing pieces from the damage.The retaining cover and metal accessory were reinstalled.The mcs tip accessory was attempted to install into the in-house monopolar curved instrument but failed due to the damage to the retaining cover, making the tip accessory appear to be dislodged on the instrument when the open and close knob is articulated.The mcs tip accessory's retaining cover exhibits damage external to the retaining bayonet, a feature of the retaining cover that engages with the instrument tube adapter of the mcs instrument.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use, which may result if the bayonets are forced outwards, typically during mis-installation or improper removal of the accessory.
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: 24050499
• Report Number: 2955842-2026-01143
• Device Sequence Number: 18497002
• 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,Followup
• Report Date (Section B): 04/03/2026

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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 03/13/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/02/2026; 04/03/2026
• 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