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

Model Number	470383-04
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the monopolar energy cable for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the device is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the surgeon observed sparks on the monopolar energy cable.The customer identified that the cover of this cable was damaged even though its appearance was intact and undamaged upon inspection before the procedure.The user completed the procedure using a backup monopolar energy cable.There was no report of fragment(s) falling inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr) and obtained the following additional information: the customer inspected the cable prior to use but found no signs of damage on its surface.During the procedure, they saw there were burn marks on the surface of this cable.The customer did not notice any abnormalities in the surgical instruments that were used in this reported procedure.There was no report of injury from the patient or the surgical staff.The csr stated there was no record of how many times this energy cable had been used prior to this procedure in this hospital.The specific date of this incident was on (b)(6) 2024 not (b)(6) 2024 and the csr became aware of this event on 31-may-2024.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The energy cable was analyzed and found to have insulation damage at the base of the end that connects to the instrument.The insulation damage was found on the white conductor wire.The conductor wires were exposed and thermal damage was observed.Additional observation(s) not reported by site included the cautery cable was found to have a broken wire at the base of the end that connects to the instrument.Visual inspection displayed signs of physical damage to the conductor wires.The brown conductor wire was completely severed.Thermal damage was observed.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 19692449
• Report Number: 2955842-2024-16480
• Device Sequence Number: 7117974
• Product Code: NAY
• UDI-Device Identifier: 00886874112595
• UDI-Public: (01)00886874112595(10)VL201101
• 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): 05/31/2024

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: 470383-04
• Device Catalogue Number: 470383
• Device Lot Number: VL201101
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• 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: Male