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

Model Number 380677-15

Device Problem Poor Quality Image (1408)

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

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse was able to reproduce the reported issue.The fse swapped the digital video interface (dvi) leads between the left and the right high resolution stereo viewer (hrsv) monitors and verified the problem did not follow.The fse replaced the affected monitor to correct the reported issue.The system was tested and verified as ready for use.The hrsv was returned to intuitive surgical, inc.(isi) for failure analysis evaluation.However, the root cause of the customer reported failure mode cannot be determined as failure analysis investigation is in progress.A follow-up mdr will be submitted upon the completion of the failure analysis and/or if additional information is received.Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair surgical procedure, the left eye of the surgeon side console (ssc) was black.The site had restarted the system with no resolution.The technical support engineer (tse) had the site perform two hard restarts with no success.The site stated that they would try to complete the surgery with one eye on the ssc, or they may convert to laparoscopic surgery.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the procedure was not converted to laparoscopic surgery.The surgeon completed the procedure robotically using the ssc with one eye, and there was no harm to the patient.

Manufacturer Narrative

4307 - intuitive surgical, inc.(isi) received the high resolution stereo viewer (hrsv) monitor involved with this complaint and completed the device evaluation.Failure analysis investigation replicated and confirmed the customer reported complaint.The hrsv monitor was observed to have no image, indicating a defective main board.

Event Description

Refer to h10/h11 for additional information.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9723189
• MDR Text Key: 191749705
• Report Number: 2955842-2020-10118
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 52 YR
• Patient Weight: 91