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

Model Number 380677-22

Device Problem Failure to Power Up (1476)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

At the end of the surgery, (isi) technical support engineer (tse) instructed the caller through troubleshooting steps.After the blue fiber cables were properly reseated, the alleged problem with surgeon side console 1 was resolved.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.The tse reviewed the system logs at the time of the call and confirmed the errors.This complaint is being reported based on the following conclusion: the customer converted after the start of the procedure due to ssc1 not power on.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it 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 surgical procedure, surgeon side console (ssc) 1 would not power on.Prior to contacting intuitive surgical inc.(isi) technical support engineer (tse), the surgeon decided to proceed with the surgery using ssc2.Tse reviewed the logs and found several errors pointing to a wheel comm issue.Because surgery was ongoing, the caller (nurse) could not go through troubleshooting steps with tse.The procedure was completed as planned with no reported injury.After surgery, the nurse followed up with tse.After power cycling the system with emergency power off and reseating the blue fiber cable, the alleged issue was resolved.System was ready for use.Isi followed up with the initial reporter and on 3/10/2022, obtained the following additional information: the reporter confirmed the alleged issue occurred after anesthesia was administered.The reporter clarified that the da vinci system was started up before the start of the anesthesia, then an error message indicating to restart the da vinci occurred.After doing so, the system was ready for use.When the surgeon went to console and placed the trocars, the system failed.Since a second console was available, the surgeon used that.Service team was informed immediately.The reporter indicated that since it was necessary to completely shut down and restart the da vinci system, this was not possible intraoperatively, so it was done after the surgery ended.The patient suffered no harm in the process.

• 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: 13992375
• MDR Text Key: 298247748
• Report Number: 2955842-2022-10870
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 380677-22
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 04/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES