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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
It was reported that the bipolar energy cable had a poor connection and showed signs of burning at the connection site.There was no report of patient involvement.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did the bipolar energy cable to perform failure analysis.Failure analysis replicated and confirmed the customer reported complaint "poor connection, burned in connection".The bipolar cautery cable was found to have thermal damage at the distal connector.The black part of the connector seems to have been melted.The insulation of the cautery cable was not damaged.The accessory passed the electrical continuity test.The cautery cable was tested on our in-house system and was functional bipolar energy was delivered.Intuitive followed up and obtained additional information.The customer informed the procedure was a proctectomy procedure.The issue was resolved by replacing the cord.The procedure was completed with no patient injury or harm.

• 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: 24192968
• Report Number: 2955842-2026-02268
• Device Sequence Number: 18520121
• 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): 03/10/2026

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: 02/12/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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