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

Model Number IS4000 A70P5D

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

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

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

Isi received the unit involved with this complaint, however, the failure analysis investigation is still in progress therefore the root cause of the customer reported failure has not been determined.A follow up mdr will be submitted once the failure analysis has been completed and/or 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 prostatectomy procedure, the right image on the surgeon side console (ssc) high resolution stereo viewer (hrsv) displayed static.The images displayed on the vision side cart (vsc) and external monitor were fine.The customer attempted to use a different endoscope but the issue persisted and the right monitor stopped working after power cycling.The surgeon made the decision to convert the procedure to another da vinci surgical system and the planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.An isi technical field specialist was dispatched to the facility and was able to reproduce the reported issue.The ssc hrsv was replaced to resolve the issue.The hrsv provides the video image for the ssc.

Manufacturer Narrative

Isi has received the device involved with this complaint and completed the device evaluation.Failure analysis investigation was unable to reproduce the reported issue.

• 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: 6675291
• MDR Text Key: 78710242
• Report Number: 2955842-2017-00401
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS4000 A70P5D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• 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