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

Model Number	430101-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a da vinci-assisted prostatectomy-simple transvesical surgical procedure, single port (sp) monopolar cautery instrument tip broke off after the procedure when the surgical tech was removing the spatula tip.The spatula tip was thrown away by the tech.The procedure was completed with no reported injury.Intuitive followed up and obtained additional information.The instrument was inspected prior to use.The surgical task was being performed when the issue occurred was the surgical tech was removing the spatula tip from instrument when it broke off, said she didn¿t think to save the spatula tip for analysis and threw it away.The contact person did not believe the instrument did not collide with any other instrument.The incident did not involve a fragment falling inside the patient.There were no tests like an x-ray or ultrasound performed to check for remaining fragments.The patient has not returned to the hospital due to the experiencing any complication related to retaining a foreign object.Patient demographics were not provided.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar cautery instrument was analyzed and found to have a broken tube adapter.The broken piece was not returned and measures approximately 3.85mm x 2.25mm in size.The instrument was found to have a broken conductor wire at the distal end at the tube adapter.No signs of thermal damage were observed.The conductor wire broke as result of the break in the tube adapter.The probable root cause of a damaged tube adapter is attributed to either tip accessory installation issues or damage during use.This issue can be resolved by using an alternate instrument to complete the procedure.

• 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: 23663494
• Report Number: 2955842-2025-46611
• Device Sequence Number: 10260290
• Product Code: NAY
• UDI-Device Identifier: 00886874124147
• UDI-Public: (01)00886874124147(10)H10250909
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: 430101-01
• Device Catalogue Number: 430101
• Device Lot Number: H10250909 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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