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

Model Number 380990-12

Device Problems Electrical /Electronic Property Problem (1198); Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

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

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

Isi received the unit involved with the complaint and completed the device evaluation.Failure analysis was able to reproduce the reported issue.The unit was installed onto a test system and it failed.White balance could not be performed due to the right eye being too bright.This problem was cause by right ccu.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 prostatectomy procedure, the right eye was too bright and unclear; however, the left eye was fine.An intuitive surgical, inc.(isi) technical support engineer (tse) confirmed both 0° and 30° endoscopes had the same issue.The tse advised to verify the camera cable connections and perform white balance again; however, an error message was displayed and the issue persisted.The customer attempted using an external illuminator but again the issue persisted.At that time, the surgeon made the decision to abort the procedure post anesthesia and port placement.A field service engineer (fse) was dispatched to the facility and was able to reproduce the reported issue.The issue was resolved by replacing the double camera controller (doco).The doco is located on the vsc and it receives and processes video signals.

• Brand Name: DAVINCI SI
• 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: 7318970
• MDR Text Key: 101857628
• Report Number: 2955842-2018-10041
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380990-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2013
• 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