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

Model Number IS4000 A70P7B

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 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) has not received the unit for failure analysis.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.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 experienced an error on the right master tool manipulator (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 surgeon side console (ssc).One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).The procedure was converted to laparoscopic surgery.There was no report of patient harm, adverse outcome or injury.(b)(4) (isi) received the following additional information: the robot worked without issue before the error occurred.Troubleshooting was performed, however, the surgeon was unable to continue with the surgery.The conversion was not planned but the case completed laparoscopically without harm to the patient.An isi field service engineer (fse) was dispatched to the site and was able to reproduce the reported failure and verified the error through the logs.The fse replaced the mtm to resolve the issue.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the master tool manipulator (mtm) involved with this complaint and completed investigation.Failure analysis investigation reproduced the reported failure during sine cycle.

• 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: 7137466
• MDR Text Key: 96037067
• Report Number: 2955842-2017-00860
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS4000 A70P7B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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