MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number A70P6B IS4000

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

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

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the unit involved with this complaint and completed the device evaluation.The failure analysis confirmed the customer reported failure.The image was very greenish on the touchscreen at startup which indicates that the light engine turned bad.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 prior to the start of a da vinci-assisted surgical procedure, a preventative maintenance advisory message displayed on the screen and a warning message indicating that the image may be degraded.The site had changed out the endoscope, shut down the system, and did a breaker reset; however, the issue persisted.The site tried a third endoscope and it connected and calibrated, but when the light was turned on, the error returned and the image had a green hue.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the system logs and found self test error 48204 pointing to the endoscope controller (ec).There was no report of patient harm, adverse outcome or injury.Isi followed up with the initial reporter and obtained the following additional information: the da vinci-assisted surgical procedure was aborted post anesthesia and port placement.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported problem.The fse replaced the ec to resolve the issue.The ec contains a high-intensity light source to illuminate the surgical site and the electronics for processing the video images from the endoscope.

• Brand Name: DA VINCI XI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7003088
• MDR Text Key: 92074708
• Report Number: 2955842-2017-00739
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A70P6B IS4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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