MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-42

Device Problem No Device Output (1435)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse spoke with customer about the arm engagement issue.The customer stated that adapter was reseated during the procedure.The customer mentioned at the end of the procedure, the surgeon noticed arm 1 began to lock up but may have been due to having his foot on the clutch foot pedal.The fse went onsite to evaluate the issue.The fse test drove the system which showed no issues.The fse mentioned to the customer that a possible range of motion of armnet could cause stiffness in intuitive motion.The other possibility was due to system the being a dual console.The surgeon possibly clicked "give" on surgeon side console (ssc) touchscreen which would cause him not to move arm 2.No part replacement was required.The system was tested and verified as ready for use.A review of the site's complaint history identified no other complaints for this product.A review of the site's system logs for the reported procedure date was conducted by a technical support engineer (tse).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.No image/video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: a universal surgical manipulator (usm) was abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.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 pulmonary lobectomy surgical procedure, the customer reported that every time they would load the instrument into arm 2; it would lock, and the surgeon would be unable to control the instrument arm.The customer stated they tried a different instrument and tried reseating the instrument, but the issue persisted.The customer stated that the surgeon decided to bring in arm 1 in place of arm 2 to complete the procedure.The system was not connected to the network during the call, so the technical support engineer (tse) was not able to view the error logs.The customer reseated the ethernet cable on the back of the vision side cart (vsc) during the call.The phone was given to the surgeon who reiterated that he could not get instruments to be recognized on arm 2.No matter how often he reseated it, he was unable to take control of arm 2 anytime that they would load instruments into the arm.The surgeon stated that he put the same instrument from arm 2 onto arm 3 and had no issues.The surgeon stated that he completed the procedure and ended the call.The procedure was completed as planned with no reported injury.The tse noticed that the system posted logs after the call ended.The tse reviewed the system error logs and discovered no system errors present in the live logs.A member of the site's biomed department followed up after case completion to confirm that onsite was connected for logs to be reviewed.The tse instructed the customer to inspect arm 2 instrument carriage for any signs of damage or issue.The customer reported that there were no issues compared to the other arms.The tsa instructed biomed to inspect presence pins and there were no issues reported.The tsa asked if biomed knew where the staff kept the training instruments.The biomed informed he did not so no further troubleshooting could be performed.The system was powered down and the customer requested that a field service engineer (fse) be dispatched.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 14158314
• MDR Text Key: 298972187
• Report Number: 2955842-2022-11149
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-42
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• 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