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

Model Number	470384-06
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The bipolar energy cable was analyzed, and the findings did not replicate or confirm the customer reported event.The reported event with the accessory could not be replicated nor confirmed.The monopolar cautery cable was installed on our in-house system and tested with an in-house instrument and was recognized; the energy delivery was performed and passed the test.No product issue was identified.The maryland bipolar forceps instrument was not confirmed or replicated.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the thermal damage was first observed intraoperatively when bipolar energy stopped.There was no arcing observed and no patient injury.The surgeon believes that maybe a wet connector caused the issue.Customer is unsure if the cord was inspected before the procedure; however, it was replaced.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the intuitive device returned.However, isi has not received the bipolar energy cable involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that the bipolar energy cable had poor connection and burned in connection.The customer reported event has no report of patient injury.

• 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 ; 4085232100
• MDR Report Key: 24166280
• Report Number: 2955842-2026-02171
• Device Sequence Number: 9112485
• Product Code: GEI
• UDI-Device Identifier: 00886874112601
• UDI-Public: (01)00886874112601(10)VL2503001
• 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,Followup
• Report Date (Section B): 02/26/2026

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: VL2503001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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