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

Model Number IS4000 (A70P6B)

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

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

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc. (isi) received the unit involved with this complaint, however, the device evaluation is still progress and has not been completed. A follow-up mdr will be submitted once the device evaluation has been completed 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 right eye of the surgeon side console (ssc) stopped working. The customer attempted troubleshooting by removing the instruments, powering down the system, reseating the blue fiber cable, cycling the ssc breaker, and powering on the system but the issue persisted. At that time, the customer made the decision to complete the procedure using another da vinci ssc. 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 confirmed that the right ssc high resolution stereo viewer (hrsv) monitor was defective. The fse replaced the monitor to resolve the issue. The hrsv provides the video image for the ssc.

• 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: 6887266
• MDR Text Key: 87877856
• Report Number: 2955842-2017-00624
• 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

• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: IS4000 (A70P6B)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse