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

Model Number 381121-31

Device Problems Poor Quality Image (1408); Defective Component (2292)

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

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

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 the reported malfunction were to recur, it could cause or it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted ventral hernia repair procedure, the right eye in the surgeon side console¿s (ssc) high resolution stereo viewer (hrsv) was black.The customer rebooted the system with no change.An intuitive surgical, inc.(isi) technical support engineer (tse) attempted troubleshooting by having the customer reboot the system once again, cycling the circuit breaker on the ssc, and cleaning and reseating the fiber 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.Isi followed up with the site¿s robotics coordinator and obtained the following additional information: the patient handled the conversion to laparoscopic surgery well.At this time, the patient is in normal recovery and in ¿very good¿ condition.The robotics coordinator estimated that approximately twenty minutes passed from the time the patient was docked to the time that the procedure was converted to laparoscopic surgery.The robotics coordinator confirmed that the image looked normal/fine while checking the system from the vision side cart touchscreen.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse confirmed that the right eye in console was not turning on.The fse noted the left eye was working fine but the right eye had no image.The fse restored the right eye image after replacing the right hrsv.The high resolution stereo viewer is located on the surgeon side console and provides the 3d image captured from the endoscope inserted in the patient.

Manufacturer Narrative

The original equipment manufacturer (oem) received the high resolution stereo viewer (hrsv) monitor associated with this complaint and completed its investigation.The oem confirmed the reported issue ¿ right is black in console.Oem found that the monitor had no image and the main board has a defect.The printed circuit assembly main board was replaced to address the reported issue.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8075673
• MDR Text Key: 128291632
• Report Number: 2955842-2018-10673
• 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
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

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: 381121-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES