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

Model Number	470383-05
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the chief surgeon reported that the monopolar energy cable had energy that was unstable.Energy was occasionally available and sometimes not; after the instrument nurse reinstalled it on the table, the energy was used normally.However, during the surgery, it was discovered that the monopolar energy cable was sparking where it connected to the instrument.After pausing the surgery, it was found that the energy cable had been burned and turned black.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the monopolar energy cable, however, intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the monopolar energy cable to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The cautery cable was found to have the insulation damage at the base of the end that connects to the instrument, causing the connector to hang.There was black residue at the site of the damage, confirming arcing and/or thermal damage.The internal wires seemed to be completely detached.The probable root cause is attributed to damage during use or reprocessing, which may include improper handling of the cable.Additional observation(s) related to customer reported complaint: the cautery cable was found to have a broken wire at the site of the insulation damage.Visual inspection displayed signs of arcing and/or thermal damage which likely contributed to the broken cable.The probable root cause is attributed to damage during use as excessive bending of the monopolar/bipolar energy cables below the connector can lead to broken wires.

• 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: 22670348
• Report Number: 2955842-2025-32245
• Device Sequence Number: 11681931
• Product Code: GEI
• UDI-Device Identifier: 00886874112595
• UDI-Public: (01)00886874112595(10)VL211801
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2025

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: VL211801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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: Reuse
• 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