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

Model Number 380610-14

Device Problem Poor Quality Image (1408)

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

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did not receive the instrument involved with this complaint.A isi field service engineer (fse) went onsite, but was unable to confirm the customer reported failure.The fse set up the video system using customer camera heads and scopes and was unable to reproduce the issue.The vision system calibrated normally with no issues, and the 3d vision looked normal in both consoles.The fse demonstrated to the customer that the vision system was functioning normally.The fse performed case observation and the customer was able to set up vision system and use it for surgery without further issues.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 contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted rectopexy surgical procedure, there was double vision in the surgeon side console (ssc).A nurse from the site contacted intuitive surgical inc.(isi) and spoke with a technical support engineer (tse).The nurse noted that the issue was not on any of the external 2d monitors.Prior to contacting isi, the operating room (or) staff had swapped to a backup camera head and cable, tried multiple scopes, and rebooted the system with no change.Tse viewed system logs and was able to confirm a corrupted scope configuration error reported by the dual camera control unit (doco).The surgeon stated that each eye by itself was functional but the issue was present when viewing both eyes simultaneously.Surgeon also stated that the issue was present on both sscs.The surgeon elected to convert to laparoscopic surgery due to this issue.There was no report of patient injury.

• Brand Name: DAVINCI SI
• Type of Device: SURGEON SIDE CONSOLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9114214
• MDR Text Key: 187229628
• Report Number: 2955842-2019-10742
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380610-14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1