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

Model Number	430004-62
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors instrument was not responding.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information on 30-mar-2026: the jaws of the instrument remained completely static while in the open position, and no broken cable was visible.
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 the findings did not replicate or confirm the customer reported event.An in-house tip accessory was installed on the instrument and placed on the in-house system.The instrument passed the recognition, engagement and tip recognition.The instrument moved intuitively with full range of motion in all directions.The instrument passed energy delivery testing in various orientations.There was no difficultly removing the instrument from the in-house system and the release buttons are functional.The instrument was retested twice and passed on both attempts.The instrument was fully functional.Visual inspection was performed and there was no external damage to the snake wrist and main tube.The housing was removed for inspection and no issues were observed.No product issue was found.Additional unrelated observation(s) not reported by site: the instrument was found to have scratch marks on the tube adapter.Upon visual inspection, the instrument was observed to have three deep scratch marks on the tube adapter near the distal tip.The instrument was also found with cracked housing.The crack measured 10.3mm in length and was located at the distal end of the of the housing.The instrument was found to have residue.During visual inspection, white residue was observed on all four of the clamping pulleys, located inside the backend of the instrument.Further, the instrument was found to have corroded bearings.The housing was removed for inspection and orange discoloration was observed on eight bearings near the clamping pulleys and inputs, which indicates corrosion.

• 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 ; 4085232100
• MDR Report Key: 24973132
• Report Number: 2955842-2026-22730
• Device Sequence Number: 4849967
• Product Code: NAY
• UDI-Device Identifier: 00886874114285
• UDI-Public: (01)00886874114285(10)K10250320
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/23/2026

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: K10250320 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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 Sex: Unknown