MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CAUTERY INSTRUMENT

Model Number	430007-57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single port monopolar curved scissors instrument to perform failure analysis.The instrument was found to have a cracked 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 cracked piece, measuring approximately 2.9mm in length.The cracked tube adapter is likely the cause of the broken electrical contacts.Visual inspection was performed and there was no damage to the snake wrist cables, housing and shaft.Each input disk was manually articulated and responded accordingly.The release buttons were functional.The probable root cause is attributed to excessive force applied to an installed tip accessory during use, such as inadvertent collisions with other instruments.Additional common causes include improper installation or removal of the tip accessory.Additional observation(s) related to the customer reported complaint: the instrument was found to have broken contacts.The electrical contacts were located at the distal tip of the instrument and was observed broken inside the tube adapter.The electrical contacts measure approximately 2mm x 2.7mm and was not returned with the instrument.The broken contacts are likely cause by the cracked tube adapter.The root cause is attributed to use conditions.The instrument was found to have a detached fragment.During visual inspection, the detached fragment was observed from the broken electrical contacts.The area of detachment measures approximately 2mm x 2.7mm and was not returned with the instrument.Additional observation(s) not reported by site: the instrument was found to have residue.Visual inspection was preformed and white residue was observed on two of the clamping pulleys, located inside the backend of the instrument.The probable root cause is attributed to improper cleaning or sterilization techniques used during reprocessing, which may involve prolonged exposure of the instrument to harsh cleaning agents or insufficient flushing.The instrument was found to have multiple corroded bearings.The housing was removed for inspection, and orange discoloration was observed on eight of the bearings near the clamping pulley, which indicates corrosion.The root cause is attributed to use conditions.
Event or Problem Description
It was reported that after a da vinci-assisted radical tonsillectomy surgical procedure, there was an issue at the tip of a single port monopolar curved scissors instrument.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CAUTERY INSTRUMENT
• 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: 25197284
• Report Number: 2955842-2026-25458
• Device Sequence Number: 8890311
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(10)U10220606
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/17/2026

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: 430007-57
• Device Catalogue Number: 430007
• Device Lot Number: U10220606 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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