MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC None; BIPOLAR CAUTERY CORD

Model Number	470384-06
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the "code" on the bipolar energy cable had melted.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer reported no sparking, smoke, fire, or thermal damage.The cable was inspected prior to the event with no damage noted, and the number of prior uses and how long it had been on site were both unknown.At the time, the cable was connected to an integrated electro surgical unit (iesu) generator using bipolar energy and was plugged into maryland and fenestrated bipolar instruments; no information was provided on whether it was connected to the correct generator port or whether a third-party generator was in use.There were no injuries, the issue was resolved by switching to a backup cable.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the bipolar energy cable for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.

• Brand Name: None
• Common Device Name: BIPOLAR 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 ; +1(408)523-2100
• MDR Report Key: 50811422
• Report Number: 2955842-2026-39187
• Device Sequence Number: 10575712
• Product Code: GEI
• UDI-Device Identifier: 00886874112601
• UDI-Public: (01)00886874112601(10)VL2519001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 470384-06
• Device Catalogue Number: 470384
• Device Lot Number: VL2519001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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