MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-11

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the unit involved with this complaint; however, the device evaluation is not completed at the time of this report.Therefore the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted when device evaluation is completed 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 surgical procedure, the right eye of the surgeon side console (ssc) had no video.The site confirmed that the vision side cart (vsc) had video in both eyes.The intuitive surgical, inc.(isi) technical support engineer (tse)instructed the customer to power cycle the system but there was no change.The site completed the procedure robotically with a single console (this was a dual console system,) 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 high resolution stereo viewer (hrsv).The hrsv provides the video image for the ssc.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the parts involved with this complaint and completed the device evaluation.The reported complaint was confirmed, there was no image and it was identified that the main board was defective.The pca main board will be replaced to fix the issue.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8453696
• MDR Text Key: 139990762
• Report Number: 2955842-2019-10223
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES