MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, 4-ARM

Model Number 380614-11

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

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

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

The rac board has not been returned to isi for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the rac is returned (post engineering evaluation) or if additional information is received.A review of the system logs confirmed the reported error.No image or video was available for review.A review of the site's complaint history does not show any additional complaints related to this event.Based on the information provided at this time, this complaint is being reported due to the following conclusion.The system unavailable after the start of a surgical procedure (first port incision) and the surgeon decided to complete the procedure laparoscopically.Although no patient harm occurred, if this malfunction were to recur it could potentially cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, non-recoverable error 26002 occurred.Emergency power off (epo) was performed; however, error 281 occurred, pointing to the remote arm controller (rac).A series of hard resets were performed including epo but the error persisted.The surgeon made the decision to convert the procedure to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the field service engineer (fse) and obtained the following additional information.The system powered on without errors and was functionally checked.The first error occurred after the procedure began when the surgeon was about to begin bladder neck dissection.The customer contacted an fse and full troubleshooting was completed with several hard power cycles and epo.The issue was unable to be resolved.The procedure was converted to laparoscopic and was completed with no patient injury.An isi fse was dispatched to the customer site to further investigate the reported complaint.The fse replaced the remote arm controller board 3 (rac3) to resolve the reported error.The system was tested and verified as ready for use.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following sections: d10, g4, g7, h2, h3, h6, h10.4307 - intuitive surgical, inc.(isi) received the remote arm controller 3 (rac3) board involved with this complaint and completed the device evaluation.Failure analysis investigation installed the board into a test system and was able to replicate the reported communication problem.Troubleshooting found the rac control module board failed to respond.This complaint remains reportable due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.Although no patient harm was reported, if the issue were to recur, it could result in an adverse event.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10041085
• MDR Text Key: 230433301
• Report Number: 2955842-2020-10474
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380614-11
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES