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

Model Number 380990-09

Device Problems Electrical /Electronic Property Problem (1198); Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the parts involved with this complaint and completed the evaluation.Failure analysis investigation installed the pmva board onto a test system and it started up with no error.The board was power cycled 10 times and passed all testing, the reported problem could not be replicated but was confirmed via error log files.The doco was installed on a test system and started up with no errors.The board was power cycled 10 times and passed all testing, the reported problem could not be replicated but was confirmed via error log files.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 was available for review.The meaning of the error was noted by technical support when the customer reported the issue.A review of the system logs confirmed the reported error had occurred.Based on the information provided at this time, this complaint is being reported because the system was unavailable after the start of a surgical procedure (first port incision) and the procedure was converted to traditional laparoscopic surgical techniques.Follow-up was attempted, but the patient information was either unknown or unavailable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during an unspecified da vinci-assisted surgical procedure, error 309 occurred indicating a problem in communication between the double camera controller (doco) and the personality module vision acquisition (pmva) board.The surgeon made the decision to convert the procedure to traditional laparoscopic techniques and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the field service engineer (fse) and obtained the following additional information: the customer experienced error 309 the prior day and restarting the system resolved the issue.The fse was dispatched to the customer site and reseated the related cables and boards.Error 309 recurred the following day approximately an hour after the procedure started.A fse advised the customer to restart the system; however, the error persisted after 3 attempts.The surgeon made the decision to convert the procedure to traditional laparoscopic techniques and the procedure was completed with no reported injury.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse confirmed the reported error and replaced the personality module vision acquisition (pmva) board, double camera controller (doco), and the cable between them.The system was tested and verified as ready for use.

• Brand Name: DAVINCI SI
• 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: 9951833
• MDR Text Key: 228838836
• Report Number: 2955842-2020-10305
• 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: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2020

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: 380990-09
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2012
• 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