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

Model Number 380677-13

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Isi has received the units for failure analysis investigation, however, the investigations are still in progress.Therefore, the root cause of the customer reported failure has not been determined.A follow-up mdr will be submitted to the fda once the failure analysis investigations have been completed and/or if additional information is received.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during the da vinci-assisted surgical procedure, the surgeon experienced multiple recoverable faults on the left master tool manipulator (mtm).The customer power cycled the system and cycled the breakers on the surgeon side console (ssc).The system powered back on and faulted once again as the surgeon attempted to take control of the instrument.The customer contacted an intuitive surgical inc.(isi) technical support engineer (tse) for troubleshooting assistance but the issue could not be resolved.At that time, the surgeon made the decision to convert the procedure to an open traditional procedure.There was no report of patient harm, adverse outcome or injury.Isi followed up with the isi clinical sales representative (csr) and confirmed that the surgeon completed the procedure successfully after converting to an open procedure.At the start of the procedure, the site had docked the system and started to use arm 1 when the system started displaying multiple recoverable faults.The recoverable faults were pointing to the instrument not ready and other issues.The csr worked with the site to undock then disable arm 1 and re-dock system to resolve issue.After restarting, more recoverable faults appeared due to another arm.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The reported issue was resolved by replacing the following the mtm and the universal surgical manipulator (usm).The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the ssc.One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the units involved with this complaint and completed the device evaluation.The investigation results are as follows: failure analysis was not able to reproduce the reported failure on the usm.The unit was installed on a test system and passed in normal mode all tests.Failure analysis was not able to reproduce the reported failure on the mtm but was able to confirm the error had occurred via system logs.Visual inspection was performed.The arm was installed onto the system and powered up.Sine cycle was performed without any issues.The axis 7 motor will be replaced as a precaution.No trouble was found with the mtm.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7625498
• MDR Text Key: 112039086
• Report Number: 2955842-2018-10304
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-13
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2018
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES