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

Model Number 381121-22

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

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

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

Isi received the high resolution stereo viewer (hrsv) for failure analysis, however, the evaluation is still in progress.Therefore, the root cause of the customer reported failure has not been determined.A follow up mdr will be submitted once the failure analysis evaluation has been completed and/or if additional information is received.The 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 myomectomy surgical procedure, the surgeon lost vision on the right eye of the high stereo resolution viewer (hrsv).The customer tried a second endoscope and the issue was still present.The customer then tried power cycling the system with no change.An intuitive surgical, inc.(isi) technical support engineer (tse) then recommended the customer to try performing a hard cycle.The customer stated that they already performed hard cycling the system.As such, the customer opted to stop troubleshooting the ssc and bring in a second ssc to proceed with the procedure.The procedure was completed with a second surgeon side console and there was no report of patient injury.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Fse was able to duplicate the issue.Fse did a hard reboot and restarted the system multiple times.Fse also swapped the blue fiber cable which did not resolve the issue.Fse replaced the right high resolution stereo viewer (hrsv) monitor and the issue was resolved.The system was tested and verified as ready for use.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following sections: g4, g7, h2, h3, h6 and h10.4307 - failure analysis investigation was completed for the high resolution stereo viewer (hrsv) associated with this complaint.Failure analysis investigation was able to replicate the customer reported complaint of no vision on right eye.The main board was found to have a defect.The printed circuit assembly (pca) 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: 8704575
• MDR Text Key: 148196892
• Report Number: 2955842-2019-10456
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

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: 381121-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES