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

Model Number IS4000 A70P6B

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 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the device involved with this complaint and completed the device evaluation.Failure analysis was not able to reproduce the reported failure during sine cycle, but was able to confirm the reported failure via error logs.Visual inspection was performed.Sine cycle was performed without any issues.Tests performed via dte and matlab passed.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 an error 1 message pointing to the left master tool manipulator (mtm) on surgeon's console.The customer contacted intuitive surgical, inc.(isi) technical support engineer (tfe) for assistance and asked the customer to power cycle the system and exercise the left mtm for several seconds.The system powered and homed successfully with no errors.The tfs informed the customer that error 1 could return and become non-recoverable.At that time, the surgeon made the decision to convert to another da vinci system.There was no report of patient harm, adverse outcome, or injury.An isi field service engineer (fse) was dispatched to the facility and was not able to reproduce the reported failure, but was able to view the error in the system logs.To resolve the issue, the fse replaced the mtm.The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the ssc.One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).

• 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: 7009958
• MDR Text Key: 92544518
• Report Number: 2955842-2017-00760
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS4000 A70P6B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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