MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-23

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

The surgeon used the other surgeon side console (ssc) to continue the procedure.The robotic coordinator later informed the field service engineer (fse) that the system, including the pedal, worked normally after a power cycle.No site visit was conducted.The system was working properly and no additional action was required.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.No image or procedure video was provided for review.The tse verified the event upon troubleshooting with the customer.A procedure log review was performed.Per the review, the following was confirmed: a simple prostatectomy procedure was performed on (b)(6) 2022 on system (b)(4).A review of the site's system logs for the reported procedure date was conducted by the tse during troubleshooting.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.This complaint is considered a reportable event due to the following conclusion: a surgeon side console (ssc) was in an unacceptable state after the start of the procedure as the foot pedal on the ssc was not functioning.The surgeon aborted the ssc and continued with the other ssc, resulting in only one surgeon completing the procedure rather than two, as was planned.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.

Event Description

It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, the customer observed the clutch pedal on surgeon side console (ssc) 2 was not working.Prior to calling, the surgeon switched to ssc1.No troubleshooting was performed.The technical service engineer (tse) reviewed the logs and found no related errors.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the nurse informed that the procedure was a dual console/surgeon prostate procedure with two console surgeons.The surgeon on ssc2 had problems with the clutch on the foot pedal not functioning.The foot pedal was working properly initially until the issue occurred towards the end of the procedure, in the last 30 minutes.The surgeon continued with only ssc1 for the remainder of the procedure and ssc2 was not used after the issue occurred.The procedure was completed robotically with no injury to the patient.Patient demographic information was requested but unavailable.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 14191435
• MDR Text Key: 299080487
• Report Number: 2955842-2022-11239
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-23
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male