MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-23

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

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

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the isi core controller (icc) involved with this complaint and completed the device evaluation.Failure analysis was able to reproduce the reported failure.The board was powered up at the test bench and found that the master supervisory controller (msc) was not booting up and becoming very hot.The field programmable gate array (fpga) has failed and needs to be replaced.Isi received the intuitive surgical core power distribution (ipd) involved with this complaint and completed the device evaluation.The failure analysis was not able to reproduce the reported failure.The tray was installed on the test system and it came up with no errors and the power button amber led was on.The tray was able to power up the system.The system ran 10 power cycles with no issues.The complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable 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 a da vinci-assisted surgical procedure, as the customer was plugging in the scope and attach it to the arm, the system shut down.An intuitive surgical, inc.(isi) technical support engineer (tse) instructed the customer to power down all carts by the breaker and do an emergency power off (epo).The customer powered the system back up but the vsc would still not power up.The tse advised the customer to use another vsc.The isi clinical sales representative (csr) confirmed that the customer used another vsc to complete the procedure.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.To resolve the issue, the fse replaced the isi core controller (icc) and intuitive surgical core power distribution (ipd).

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7469910
• MDR Text Key: 106876194
• Report Number: 2955842-2018-10162
• Device Sequence Number: 1
• Product Code: NAY
• 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
• Type of Report: Initial
• Report Date: 04/02/2018

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: 381121-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1