MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number 380610-21

Device Problem Poor Quality Image (1408)

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

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

The ssc high resolution stereo viewer (hrsv) has not been returned to isi for evaluation.The root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.Based on the information provided at this time, this complaint is being reported because system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.Although no patient harm occurred, if this malfunction were to recur it could potentially cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the right eye image turned black on the surgeon side console (ssc).A field service engineer (fse) advised the customer to swap the left and right signals on the vision side cart touchscreen and it was confirmed that both images were good; however, the right image on the ssc was still dark.The surgeon made the decision to convert the procedure to traditional laparoscopic techniques and completed the procedure with no injury reported.An fse was dispatched to the customer site to further investigate the reported complaint.The fse confirmed the reported issue and the ssc high resolution stereo viewer (hrsv) was replaced after troubleshooting.The system was tested and verified as ready for use.

Manufacturer Narrative

Additional information can be found in the following sections: d10, g4, g7, h2, h3, h6, h10.Intuitive surgical, inc.(isi) received the component involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The high resolution stereo viewer was installed onto a test system and confirmed there was no image due to a main board defect.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Type of Device: SURGEON SIDE CONSOLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9610888
• MDR Text Key: 196774930
• Report Number: 2955842-2020-10039
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380610-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES