MAUDE Adverse Event Report: INTUITIVE SURGICAL INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number 380610-15

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 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the unit for failure analysis.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated 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 a da vinci-assisted radical cystectomy procedure, the customer experienced multiple non-recoverable errors.All patient side manipulators (psm) were alarming red and there was no image in the surgeon side console (ssc).The intuitive surgical, inc.(isi) technical support engineer (tse) attempted troubleshooting by restarting the system a couple of times and reseating cables but the issue persisted.At that time, the surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques.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.The fse replaced the personality module surgeon console (pmsc) to resolve the issue.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis reproduced the reported failure.The unit was installed into the system and it failed to start.

• Brand Name: DAVINCI SI
• Type of Device: SURGEON SIDE CONSOLE
• Manufacturer (Section D): INTUITIVE SURGICAL INC; 1020 kifer road; sunnyvale CA 94086
• MDR Report Key: 7290442
• MDR Text Key: 100913979
• Report Number: 2955842-2018-10013
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380610-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Date Manufacturer Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES