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

Model Number 380677-06

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 12/03/2020

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 confirmed that the surgeon back plane (sbp) board failed causing a recognition failure in the head sensor section of the ssc. To resolve the issue, the fse replaced the sbp board and remote arm controller (rac). The system was tested and verified as ready for use. Isi received the parts involved with this complaint and completed the device evaluation. Failure analysis investigation replicated/confirmed the reported failure. The sbp was installed onto a test system and tested with the rac which it came back with. Ten power cycles were run and the parts were left sitting idle for one hour. After an hour, error 1150 did occur. Error 1150 was found to be caused by the sbp as opposed to the rac. No trouble was found with the rac. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or video clip for the reported event was submitted for review. Based on the information provided at this time, this complaint is being classified as a non-reportable event because: system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, error 1150 occurred and the customer tried to power cycle but error 500 occurred. The customer contacted intuitive surgical, inc. (isi) technical support to report the issue. The technical support engineer (tse) advised the customer to hard power cycle the surgeon side console (ssc); however, the issue persisted post following the tse's instruction. The customer reportedly decided to proceed laparoscopically with the procedure. Isi followed up with the initial reporter and obtained the following additional information: the system functionality was checked upon powering on the system and the system initially powered on without errors. Ports had been placed at the time of the issue's occurrence. All troubleshooting was completed with technical support; however, the issue persisted so the customer decided to convert to laparoscopic surgery. The procedure was completed laparoscopically and no injury occurred to the patient.

• 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
• 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: 11074893
• MDR Text Key: 241730489
• Report Number: 2955842-2020-11405
• 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: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 380677-06
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A