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); Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

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

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the unit involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.The failure was verified on the test system when the endoscope controller (ec) was installed and it came up with a green light.The video on the vision side cart (vsc) monitor and the hrsv had an overall green hue to it.The p1 value of the error code is 2 which means that no light was detected from the ec.The light engine has gone bad and needs to be replaced.This complaint is being reported due to a da vinci system malfunction rendering the da vinci 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 nissen fundoplication procedure, green vision in all of the monitors as well as inside of the surgeon's viewer was observed.The customer indicated that whenever the light was turned on, the green tinted vision would appear.The isi technical support engineer (tse) viewed the system event logs remotely and was able to confirm multiple errors 48204 indicating illuminator sensor self test failures.The tse advised the customer to power down the system and to perform an emergency power off (epo)/breaker toggles at the patient side cart (psc), vision side cart (vsc), and both surgeon side consoles (sscs) and restart system but issue persisted.The tse then had customer restore vision settings at the vision tower but the issue persisted.There was no report of patient harm, adverse outcome or injury.On august 15, 2017, intuitive surgical inc., (isi) obtained the following additional information from the initial reporter: it was confirmed that an si da vinci system was brought in to complete the procedure successfully.The isi field service engineer (fse) conducted a site visit to inspect the system.The system powered on and homed with no issues.The fse installed an endoscope to test the image.When the light was turned on, the image in all the monitors were illuminated with a green light instead of a white light.The fse then reviewed the event logs and found the error code 48204.To correct the issue, the fse replaced the endoscope controller (ec).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: 6847698
• MDR Text Key: 85633329
• Report Number: 2955842-2017-00591
• 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: Other
• Type of Report: Initial
• Report Date: 08/14/2017

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: A70P6B IS4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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