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

Model Number 381121-18

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The fse replaced the endoscope controller (ec) and video processor (vp) to resolve the issue.The system was tested and verified as ready for use.The products associated with this event have been returned and evaluated by the failure analysis team.The investigations are seen separated below.  video processor: failure analysis could not reproduce the reported issue, however, the error was confirmed via system logs.The vp was returned with the ec and tested together.The vp started up with no error and good video in both eyes.Fifty power cycles were performed and passed.Both vp and ec remained in the test system for 2 hours and performed with no anomalies.There was no trouble found.A review of the error logs for the remote system found that the system was logging the 1100 error on both the a side and the b side power supplies at the same time and both had the ac fail bit set, this can only happen if the core lost ac power.This suggests that the site was having power issues or the ac connection to the core was loose at the power strip in back of the vsc.  endoscope controller: failure analysis could not reproduce the reported issue, however, the error was confirmed via system logs.The ec was returned with the vp and tested together.The ec was installed in the test system.The ec started up with no error and good video in both eyes.Fifty power cycles were performed with both units and passed.Both vp and ec remained in the test system for 2 hours and performed with no anomalies.There was no trouble found.A review of the error logs for the remote system found that the system was logging the 1100 error on both the a side and the b side power supplies at the same time and both had the ac fail bit set, this can only happen if the core lost ac power.This suggests that the site was having power issues or the ac connection to the core was loose at the power strip in back of the vsc.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.There was no photo or video received for analysis.This complaint is being reported because system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure being aborted.Although there was no patient injury reported, if this issue were to recur, it could cause or contribute to an adverse event.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted prostatectomy procedure, the connection was lost between the surgeon side console (ssc) and the vision side cart (vsc).The technical support engineer (tse) asked the customer to reseat the blue fiber cable (bfc) and power cycle the system but nothing changed.The vsc did not work and the power button stayed off.The tse asked the caller to plug in the vsc on another outlet and the vsc started properly but the video signal did not come up.The touchscreen remained black.All leds on the endoscope controller (ec) were off.During the last restart, error 319 came up at the ssc.The surgeon decided to convert to laparoscopy.There was no reported injury.The customer called back and stated that the procedure was cancelled and postponed.Later, the customer conducted further troubleshooting and found that the ec or vp did not work.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 10126287
• MDR Text Key: 226995586
• Report Number: 2955842-2020-10542
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2020

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: 381121-18
• Device Catalogue Number: 381121
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1