MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist SP; MONOPOLAR CURVED SCISSORS

Model Number	430004-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single port monopolar curved scissors (mcs) instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found to have a dislodged mcs coupling at the distal.The entire mcs coupling was found to be dislodged and detached and was not returned with the instrument measured approximately 0.248" x 0.098" in size.No damage was found on the drive rod.The grip knob was manually rotated, and the drive rod was able to move up and down.Visual inspection found no damage on the tube adapter, snake wrist disks and snake wrist cables.The instrument housing was removed and no damage observed.Manual articulation was performed and the instrument moved intuitively with full range of motion in all directions.The probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, a single port monopolar curved scissors (mcs) instrument had a missing internal pin.The procedure was completed with no reported injury.

• Brand Name: EndoWrist SP
• Common Device Name: MONOPOLAR CURVED SCISSORS
• 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 ; +1(408)523-2100
• MDR Report Key: 50207792
• Report Number: 2955842-2026-35267
• Device Sequence Number: 16043747
• Product Code: NAY
• UDI-Device Identifier: 00886874114285
• UDI-Public: (01)00886874114285(10)K11250313
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 430004-62
• Device Catalogue Number: 430004
• Device Lot Number: K11250313 0001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 211 LB
• Patient Race: White