MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS3000 A60P9B

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198)

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

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the units involved with the complaint and completed the device evaluation.Failure analysis was unable to reproduce the reported issue.The gpd board was installed on the test system and the system came up with no error and all voltages present.The system ran 10 power cycles with this board with no errors or any other issues.The breaker was switched open on the test system to try to induce the error and after power cycle the 802 error code was logged.The breaker was then switch back to close and power cycled and the error was gone indicating the battery breaker may have been open when the error was logged by the remote system.Failure analysis was unable to reproduce the reported issue.The rac was inspected and no burned connector was found.The unit was installed in the test system and worked fine without any problems or errors.The pbp was inspected and a burn spot on a connector was verified; however, there were signs of contamination on the board.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 this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the customer noted a repeated non-recoverable fault displaying error code 802 indicating a battery related error.The surgeon made the decision to convert to open surgery.There was no report of patient harm, adverse outcome or injury.A field service engineer (fse) was dispatched to the facility and found errors 802 and 810 with no power at the endoscopic camera manipulator.The patient back plane (pbp) was burned around the connector the remote arm controller 3 board (rac3).The generic power distribution board (gpd), rac3, and pbp were replaced to resolve the issue.Gpd board sends control signals to the apb as well as monitors the output from the apb.The rac refers to the printed circuit board that receives signals from the rac control module (rcm) which performs all of the control, monitoring, communications, and upper-level safety functions.The pbp is a board on the patient side cart (psc) to which everything connects to.

• Brand Name: DA VINCI SI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7043554
• MDR Text Key: 93061957
• Report Number: 2955842-2017-00777
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS3000 A60P9B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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