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

Model Number	470383-05
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the monopolar instrument energy cable that was connected to an external generator (fx8 covidien) allegedly smoked and caught fire.According to the report, the generator coag setting was at value 55 and cut 45.The user continued with the procedure using the same system.No known impact or patient consequence was confirmed.Intuitive surgical, inc (isi) followed up with the initial reporter and obtained the following additional information regarding the reported event: the accessory was inspected prior to use, and it was normal.The monopolar coag was activated when the monopolar cable suddenly smoked and caught fire.The cable was connected properly.No known impact or patient consequence was confirmed.Isi conducted another follow up and information from the nurse confirmed that a monopolar energy instrument was in use; however, was unable to confirm the specific monopolar energy instrument connected to the monopolar energy cable and external generator.The site confirmed that they are using an external generator (fx8 covidien) which is not validated for use with the da vinci system.No injury was confirmed on the patient and the user who was operating the system.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the monopolar instrument energy cable involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.Inspection found burnt marks where the broken wire was located.The cable was broken into two segments when returned.The cable was found with a damaged (cut open) insulation.A review of the submitted image was performed by an intuitive surgical, inc.(isi) regulatory post market surveillance (rpms) analyst.The following additional information was provided: the image confirmed that the monopolar instrument energy cable has a burn mark and was broken.No conclusive determination could be made based on the image review.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The monopolar energy cable was transferred to the failure analyst engineer (fae).Initial failure analysis was confirmed, the cable was 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 failure observed can also be caused by grasping the wire instead of the connector body when disconnecting the cable from an instrument.The insulation exhibits thermal damage, and it appears to be incidental damage potentially caused by the failure of the insulation of the internal conductors.If the insulation between the two conductors were compromised, it is possible for an arc to result, which can lead to thermal damage of the insulation.Additionally, the cable was transferred to supplier engineering for further analysis.The cable underwent ct scanning to determine if any of the internal components could lead to an internal short circuit, but nothing was found.

• Brand Name: NONE
• Common Device Name: MONOPOLAR CAUTERY CORD
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18440043
• Report Number: 2955842-2023-21895
• Device Sequence Number: 7033853
• Product Code: GEI
• UDI-Device Identifier: 00886874112595
• UDI-Public: (01)00886874112595(10)VL213901
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: VL213901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2021
• 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