MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; MONOPOLAR CAUTERY CORD

Model Number	470383-05
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the high frequency monopolar instrument cable end caught fire, causing the cable to burn out.The cable was removed and replaced with a backup.Following this, the user continued and completed the procedure with no further issues.No fragment fell into the patient.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi), has not received the da vinci product with an alleged issue to perform failure analysis.The review of the provided image is performed by isi regulatory postmarket surveillance analyst and confirmed that the image is consistent with the reported complaint regarding the damaged monopolar cable.The root cause of the failure mode cannot be confirmed without the returned device.
Additional Manufacturer Narrative
Correction- h8 updated to indicate initial use of device.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer stated that there were not any warning signs before the fire started.The cable was connected between a force triad and monopolar curved scissors (mcs) instrument.There were no injuries or damage to other equipment or cable nearby.The fire did not affect the patient.To prevent future occurrences, the cables will be replaced.The surgeon believes that the aging cable is what caused the arcing event.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The monopolar energy cable was analyzed and found to have a broken wire at the base of the end that connects to the instrument.The wire was completely severed and displayed signs of thermal damage.The insulation was damaged and there was black charring on the cable's connector end.The complaint regarding the monopolar high-frequency cable instrument end caught fire, causing the cable to burn out was confirmed by failure analysis.The probable root cause of thermal damage is attributed to damage during use as excessive bending of the monopolar/bipolar energy cables below the connector can lead to broken wires.The probable root cause of a broken cable is attributed to damage during use or reprocessing, which may include improper handling of the cable.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The product has been evaluated by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The initial failure analysis was confirmed.The monopolar energy cable was analyzed and found to have both internal wires broken as well as the outer insulation broken.The break in the wire was observed to be at the instrument end of the cable, at the end of the connector's strain relief.The insulation also exhibited thermal damage.The complaint regarding the monopolar high-frequency cable instrument end caught fire, causing the cable to burn out was confirmed by failure analysis.The probable root cause is attributed to damage during use or reprocessing, which may include improper handling of the cable.

• Brand Name: NONE
• Common Device Name: MONOPOLAR CAUTERY CORD
• 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: 23078946
• Report Number: 2955842-2025-37993
• Device Sequence Number: 9812210
• Product Code: GEI
• UDI-Device Identifier: 00886874112595
• UDI-Public: (01)00886874112595(10)VL204401
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2026

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: 470383-05
• Device Catalogue Number: 470383
• Device Lot Number: VL204401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 10/30/2025; 02/03/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/24/2025; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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