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

Model Number IS4000, A70P7B

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the devices involved with this complaint and completed the device evaluation.Failure analysis results are as follows: mtm: failure analysis investigation was able to reproduce the customer reported failure mode during since cycle.The esmb pca, main wire harness will be replaced in the mtm to resolve the issue.Rac: the rac was installed and tested; however, they were unable to configure this unit in the system.The rcm will be replaced and the lvds module will be cleaned in the rac to resolve the issue.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 system generated multiple non-recoverable 307 errors pointing to the left master wheel net.An intuitive surgical, inc.(isi) technical support engineer (tse) advised the customer to power cycle the system multiple times, cycle all the main breakers, and emergency power off the system, however, the issue persisted.The tse then instructed to power off the system then disconnect the blue fiber cable from surgeon side console (ssc) 1 and connect it to ssc 2.At that time the system powered up no issues.It was confirmed that the site completed the robotic portion of 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 confirm the reported failure.The fse replaced the left master tool manipulator (mtm) and remote arm controller (rac) board to resolve the reported error.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).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.

• 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: 7053135
• MDR Text Key: 93435109
• Report Number: 2955842-2017-00789
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• 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: 11/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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