MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MARYLAND BIPOLAR FORCEPS

Model Number	420172-18
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm maryland bipolar forceps could not output energy.The procedure was completed with no reported injury or harm to the patient.
Additional Manufacturer Narrative
The maryland bipolar forceps has been returned and evaluated by the failure analysis (fa) team.The instrument passed the manual articulation of inputs.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened, closed and grasped properly.The instrument passed the electrical continuity and energy delivery tests in various grip orientations.Failure analysis could not verify the customer reported event.Additional observation(s) not reported by site: the instrument was found to have damaged conductor wire insulations of both wires at the yaw pulley.The internal conductor wires were exposed.No thermal damage was found on the instrument.The instrument passed the electrical continuity test.Although the conductor wire insulation was damaged, the internal wire was not frayed or fully broken.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.

• Brand Name: ENDOWRIST
• Common Device Name: MARYLAND BIPOLAR FORCEPS
• 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: 24860526
• Report Number: 2955842-2026-21336
• Device Sequence Number: 21470089
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(11)231130(10)K10231130
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 420172-18
• Device Catalogue Number: 420172
• Device Lot Number: K10231130 818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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 Sex: Unknown