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

Model Number IS4000

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the unit involved with this complaint and completed the device evaluation.The acp board was returned for failure analysis for error code 32100 which means that an arm frl was hit because of a hardware iv monitoring error.The board was installed in the acp3 slot of an in-house test system and it came up with no errors and all the gantry motors were driven through their full range of motion with no issues.The system was deployed for draping with no issues but when the arms were being stowed the system threw error 32100 as the gantry was being lowered.However, the error did not get logged since it was intermittent.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 hysterectomy procedure, the customer experienced repeated recoverable errors 32100 pointing to axes controller platform (acp3).The customer was able to recover the fault and continue with the procedure.However, the errors reoccurred, and the customer was unable to recover the fault.The site contacted an intuitive surgical, inc.(isi) technical support engineer (tse) for troubleshooting but the issue persisted.At that time the site decided to bring in another patient side cart (psc) from another system to complete the procedure.It was confirmed that the site completed the procedure with no further issues.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.The fse replaced the acp3 to resolve the issue.The acp refers to the motor driver boards to drive the patient side cart (psc) and gantry motors.

• Brand Name: DA VINCI XI 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: 7179548
• MDR Text Key: 96970712
• Report Number: 2955842-2018-00021
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS4000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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