MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CAUTERY

Model Number	420142-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted malignant tongue base resection surgical procedure, the 5mm monopolar cautery instrument was found to have a broken tip.The procedure was completed with no reported patient injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar cautery was analyzed and found during the procedure, the instrument was found to be non-functional, and a broken tip was observed.Failure analysis determined that the primary failure¿broken instrument grip tips¿was consistent with the customer complaint.Visual inspection confirmed a broken tip completely detached from the distal end, and the detached piece was not returned with the instrument.The complaint was confirmed by failure analysis.The probable root cause of the broken instrument grips -tips and detached fragment is attributed to damage during use from applying excessive force on the instrument shafts or tips during handling, insertion, usage, or removal.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MONOPOLAR CAUTERY
• 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: 23889810
• Report Number: 2955842-2025-49631
• Device Sequence Number: 4706713
• Product Code: NAY
• UDI-Device Identifier: 00886874111406
• UDI-Public: (01)00886874111406(10)T10180720
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 420142-09
• Device Catalogue Number: 420142
• Device Lot Number: T10180720 693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2018
• 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